QA Officer – Teesside

Sarah Farrow is recruiting for a QA Officer to join a global pharmaceutical company at their site in Teesside on a permanent basis.

In this position your responsibilities would include, reviewing all GMP documentation from a QA angle, carrying out audits and providing support to the manufacturing team.

To apply for this position you should have QA experience, ideally in a GMP manufacturing environment.

If you would like to join a global pharmaceutical company that provides excellent opportunities and benefits, click here

 

 

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Quality Management Systems Officer

Sarah Farrow at CK Science is recruiting for a Quality Management Systems Officer for a position at a leading pharmaceutical company based in Sunderland.

You will mainly be responsible for the preparation, review and update of SOPs, logging and investigating things such as deviations to the norm or customer feedback. In addition to this, you will be involved in auditing and inspections internally and externally.

To be considered for this role, you must have experience in a QA position and be qualified to a HNC level or the equivalent in a relevant scientific field.

For more information on this role, please click here

 

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Jobs of the week!

Here are our latest jobs in this week 04/07/2014:

Scotland:

Lab Analyst – Irvine

QA Manager – Stirling

Technical Analyst – Montrose

 

Southern England:

Lab Analyst – West Sussex

SHE Coordinator – London

Material Scientist – Hertfordshire

Production/Materials Planner – London

HPLC Research Analyst – Essex

Chemist – Oxfordshire

Mass Spectroscopist – Essex

Quality Coordinator – Berkshire

 

Midlands:

Analytical Chemist – Staffordshire

Senior Polymer Chemist – Northamptonshire

QC Analyst – Northamptonshire

 

Northern England:

Senior Scientist – South Yorkshire

Pharmaceutical Technologist – Barnard’s Castle

Shift Chemist – Halifax

Fermentation Scientist – Teesside

Operator – Liverpool

Fermentation Process Technician – Liverpool

 

To search all of our jobs, please click here

 

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Shift QA Technician – South Lincolnshire

Hannah Oakley is recruiting for a Shift QA Technician to join a well known, privately owned beverages company in South Lincolnshire on a full time, temp to perm basis.

Responsibilities in this role include carrying out routine product testing, completing all record keeping and paperwork associated with quality measurements and conducting GMP and Hygiene assessments across the entire manufacturing operation to ensure continued improvement of site and operation.

This role requires a QA Technician with Level 2 Food Hygiene Training, understanding of HACCP and a commitment to working a 2pm to 10pm shift.

For more information or to apply for this role click here

 

 

 

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Are you looking for a QA job?

If so contact CK Science today! We currently have a number of junior and senior level QA roles based in London, Hertfordshire and Bedfordshire, such as:

  • QA Officers
  • QA Execs
  • QA Managers
  • QA Auditors
  • QA Validation experts
  • Qualified Person (QP)

So if you have experience in QA area and some of the following skills:

  • Batch review
  • CAPA
  • Continuous improvement
  • Auditing
  • ISO: 9001
  • ISO: 13485
  • ISO 17025
  • RCA:
  • Medical Device Directive MDD
  • In Vitro diagnostics directive IVDD
  • MHRA
  • FDA
  • UKAS
  • IQ, OQ, PQ
  • GMP, GLP
  • CMC
  • IMP
  • Specials

WIth a background in either pharma, biotech, chemical or med devices/diagnostics then call us on 01438 723 500 or click here to search our QA jobs

 

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Global Raw Material Compliance Coordinator

Jason at CK Science is recruiting for a Global Raw Material Compliance Coordinator to join a global pharmaceutical company at their UK Site in London/Kent on a full time, permanent basis.

Our client designs and supports advanced coating systems, modified release technologies and functional excipients for pharmaceutical dosage form and are looking for someone to manage the Raw Material Risk Assessment programme.

If you have experience in a QC, A or regulatory affairs at an intermediate level, and are competent at the day to day management of base raw material data and specifications in the Oracle Quality Module and Master items, our client would like to speak to you.

For more information on this role and to apply click here

 

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Supply Chain Manager – London

Andrew Bolton is recruiting for a Supply Chain Manager to join a leading Materials Manufacturer at their site in London, on a full time, permanent basis.

They are looking for someone to manage their high value, long term supplier contract including coordinating the re-tendering process. The responsibilities also include monitoring contract performance including financial analysis, budget maintenance and reporting and leading dispute resolution.

If you have proven negotiation and relationship management skills and can demonstrate experience in managing high value supplier contracts this could be the job for you.

Click here to read the full job description and to apply

 

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Amgen and Astellas Announce Japanese Link

US biotechnology giant Amgen has entered a partnership with Astellas Pharma of Japan in order to provide for the medical needs of Japanese patients, reports www.chemweek.com.

A new business model, combining both companies’ capabilities has been agreed. Amgen’s pipeline candidate drugs are to be joined with Astellas’ knowledge and presence in the Japanese market. Five of Amgen’s pipeline developments, for the treatment of diseases of a cardiovascular nature as well as cancer, are set to be further commercialised and progressed.

A joint venture company will also be established, with the name Amgen Astellas BioPharma, with the intention of enabling Amgen to quickly establish a significant presence in Japan. This is expected to be set up and running by 1st October 2013.

Are you looking for a job in the science industry?

Click here to see our current science jobs

Pharmaceutical Jobs      

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Stability Coordinator – Sussex

Julie Marshall at CK Science is currently recruiting for a Stability Programme Coordinator to join a QA department  for a pharmaceutical company  based in Sussex on a full time, temporary basis for 12 months

Responsibilities:

As Stability Programme Coordinator you will be responsible for:

  • Requesting, receipt and delivery of stability samples
  • The design of Stability Protocols, influencing content and processes and exerting advocacy for regulatory and QMS requirements
  • Set up and management of stability studies in electronic (LIMS) systems, including troubleshooting
  • Owning the process for preparation, labelling and storage of stability samples within temperature and humidity controlled environmental chambers in accordance with approved protocols and procedures
  • Approving and reporting data generated by the laboratories and contributing to the review of laboratory OOS/ OOT investigations and deviations to identify trends and preventative actions

Qualifications and skills:

The successful Stability Programme Coordinator will have the following qualifications, skills & experiences:

  • Degree in a relevant subject (or equivalent) or experience in a role that demonstrates technical understanding of equipment and processes
  • Comprehensive knowledge of worldwide stability regulations
  • Stability data interpretation and use of appropriate tests  
  • Good understanding of the QMS and change control system in particular
  • Knowledge and experience in stability regulations

If successful, you will be joining a global company and in return there is an attractive salary and career progression opportunities.

How to apply:

Apply online:

Julie Marshall - Senior Account Manager at CK ScienceFor more information or to apply for this Stability Programme Coordinator position, please contact Julie Marshall via email jmarshall@ckscience.co.uk  or  telephone 01438 723 500. Please quote reference ST24533 in all correspondence.

Click here to see our latest jobs in the pharmaceutical industry

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Site QA Lead – West Midlands

Hannah Milward at CK Science is currently recruiting for a Temporary Site QA Lead to join a pharmaceutical and biotechnology company at their site in the West Midlands

 

The Job:

A Site Quality Leader is responsible for ensuring quality and regulatory compliance of the facility, while driving process effectiveness and efficiency. The Site Quality Leader represents the company to external agencies and champions the evolution of the quality culture for the site.

Responsibilities:

Key responsibilities of this Site Quality Leader role will include:

  • Directing the Site Quality Management System, fully integrated into the Global Quality Management System, including cross-functional and site-specific processes. The role is responsible for facility compliance covering voluntary, regulatory and company quality requirements and will champion quality initiatives at all levels of the organisation.
  • Maintaining and improving all aspects of Site Quality Planning.
  • Overseeing all Quality-related communications and training requirements for all site employees
  • Establishing positive relationships with outside agencies
  • Hosting Quality System audits and inspections
  • Overseeing the Corrective Action / Preventive Action activities and Complaint Handling Programs, and in some cases, Quality Engineering
  • Report on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews
  • Driving the definition of site quality objectives, metrics, reporting and operating mechanisms
  • Participating in selected global initiatives to share best practices and leverage quality synergies
  • Supporting local R&D programs and quality issue resolution
  • Acting as Management Representative for Quality at the Site
  • Operates a Local Inspection program and manages f/up activities to close NCs.

Qualifications:

To be considered for this Site QA Lead role you will have:

  • A Bachelor’s degree or equivalent in Engineering, Medical Device Technology or Scientific Field
  • You will have an understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry.
  • You will also have hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.

How to apply:Hannah Milward - Recruitment Consultant at CK Science

Apply online: 

For more information or to apply for this Site QA Lead role please contact Hannah Milward on 0114 283 9956 or email hmilward@ckscience.co.uk.  Please quote reference SH24376 in all correspondence.

Are you looking for a new QA job? Click here to see our other QA roles

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QA Auditor Job in Sussex

Julie Marshall at CK Science is currently looking for a QA Auditor to join the Quality Auditing team of a successful pharmaceutical company based in Sussex.

This QA Auditor role is a full-time, temporary role. If successful, you will be joining a global company and in return there is an attractive salary, coupled with career progression opportunities.

To be considered for this Quality Assurance Auditor position, you will have the following qualifications, skills and experience:

  • Experience in performing and maintaining compliance audits in line with Regulatory and QMS requirements
  • Experience in leading Audits, including scheduling, planning, executing, reporting and CAPA management
  • A degree (or equivalent) in an appropriate discipline or related experience
  • Knowledge of GMP regulations and in-depth knowledge of Quality Management Systems
  • Certified Auditor/Internal/External
  • Experience within a quality function or from a quality based role within manufacturing

How to apply:

Julie Marshall - Scientific Recruitment Consultant at CK Science

Please contact Julie for more details.

Click here to apply online now.

For more information regarding this QA Auditor position, please contact Julie Marshall at CK Science on 01438 723500 or email jmarshall@ckscience.co.uk. Please quote reference ST24342 in all correspondence.

Not quite right? Click here to search our other Quality Assurance jobs online now.

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QA Manufacturing Support Engineer – Yorkshire

Hannah Milward at CK Science is currently recruiting for a Quality Assurance Support Engineer to join a large multinational organisation involved in the treatment of musculoskeletal systems with products that include joint implants, trauma devices and biologic products. This will be on a contract basis for approximately 6 months at their site in West Yorkshire.

Job role:

The purpose of this Quality Assurance Support Engineer job is to provide quality engineering, process excellence support in a defined business unit / value stream environment for in-process, finished product, first articles and new product introduction.

Responsibilities:

As a Quality Assurance Support Engineer you will:

  • Actively support all Compliance Initiatives with the Value Stream and Plant
  • Actively support all defined Value Stream and Plant goals and objectives.
  • Identify projects to resolve scrap, reprocessing and special causes that have a negative impact on Value Stream and Plant Goals and Objectives.
  • Compile Quality Process Specifications for new/transferred products/processes
  • Be responsible for the introduction and correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
  • Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new products. Quality process specifications to be compiled for on site production and purchased for resale goods (Goods In Check procedures)
  • Reviews product designs, test protocols and co-develop critical characteristics/tolerances for initial testing and validations and subsequent routine manufacturing controls.
  • Assist and where appropriate lead in the compilation and execution of validation protocols for new product/processes and software.
  • Ensure correct implementation as per standard validation procedures.
  • Re-validate as required due to engineering change, deviation analysis or upgrade in systems and materiel.
  • Manage QA related change control for specific projects as directed
  • Participates in process evaluations (e.g. FMEAs).
  • Devises and implements methods and procedure for inspecting, testing and evaluating plans for subsequent routine production.
  • Support Quality System activities within manufacturing cells such as Internal Audits, complaint investigations, close call and corrective action investigations.
  • Perform/document dimensional/visual inspections and non conformance and deviations as required
  • Manage a variable workload to meet operational requirements.
  • Ensure that all Health, Safety and Environmental requirements are fulfilled.

Qualifications and experience required:

The successful candidate for this Quality Assurance Support Engineer job must have an engineering degree or equivalent in quality, manufacturing, engineering and/or experience in quality assurance/engineering. They must also have:

  • Proven track record in Compliance & Continuous improvement projects
  • Basic PC Skills.
  • Ability to interpret engineering drawings/specifications.
  • Familiarity in areas of various Inspection Techniques.
  • Process Excellence Green Belt/Black Belt
  • Working knowledge of Quality Systems (FDA/ISO) within a regulated environment

They will also have the following skills:

  • High Attention to Detail
  • Pro-active approach to Work
  • High Standards
  • Flexible
  • Excellent Communication Skills
  • Analytical Skills
  • Team Player
  • High level of Numeracy
  • Highly Computer Literate
  • Planner & Organiser
  • Active Listener
  • Technical Report Writing

How to apply:

Apply online now:

For more information or to apply for this Quality Assurance Support Engineer  role please contact Hannah Milward at CK Science on 0114 283 9956 or email hmilward@ckscience.co.uk. Please quote reference SH23883 in all correspondence.

Are you looking for a job in medical devices? Click here to see our latest medical device jobs now

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QA Specialist (Temp) – Northern Scotland

Graeme Pallas at CK Science is currently recruiting for two QA Specialists to join a multi national pharmaceutical company to work with them on initially a temporary contract until the end of 2012.

Responsibilities:

The successful candidate for this QA Specialist role will be responsible for driving a quality culture throughout site ensuring that products and services meet the necessary regulatory requirements.  In addition, you will support the maintenance and operation of the quality system including change control, deviations and CAPA.  You may also participate in both internal and external audit programmes.

Qualifications:

As a QA Specialist you will be qualified in a life sciences subject and or/or have demonstrable experience working in the quality assurance function of a manufacturing organisation.

How to apply:

For more information or to apply for this QA Specialist role please contact Graeme Pallas on 0191 384 8905 or email gpallas@ckscience.co.uk. Please quote reference DH23588in all correspondence.

                                                       Click here to apply online now!

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CE Marking Specialist (Medical Device) – Suffolk

Reena Dhana is currently looking for a CE Marking Specialist to join a chemical manufacturing company for a short term contract based in the Suffolk region.

Responsibilities:

As a CE Marking Specialist you will be involved in ensuring CE Marking for a biocide used to clean floors and equipment for a tender.

Experience:

For this CE Marking Specialist role you will require extensive experience of CE Marking in ideally the Medical Device or related industry.

How to apply:

For more information or to apply for this CE Marking Specialist role please contact Reena Dhana on 01438 728 500 or email rdhana@ckscience.co.uk. Please quote reference ST23076 in all correspondence.

                                                          Click here to apply online!

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Director of Quality Assurance Job in North West, UK

Jim Gleeson at CK Science is currently recruiting for a Director of Quality Assurance to join a successful molecular diagnostics company based in the North West, UK.

The role:

As Director of Quality Assurance, you will oversee all Quality Assurance activities for the manufacture of in-vitro diagnostics. Further responsibilities will include:

  • Management of the company’s Quality System
  • Close interaction with senior management and international regulatory authorities
  • Ensuring the highest levels of compliance with all applicable standards and regulations
  • Mentoring and development of staff across QA, QC and Compliance
  • Selection of methods, techniques and evaluation criteria in order to obtain robust results

 

The ideal candidate:

  • Jim is looking for candidates with the following skills, experience and qualifications:
  • Extensive GMP QA management experience, ideally within the diagnostics / medical device arena
  • Experience of hosting and managing FDA and other regulatory inspections (ISO 13485 would be particularly useful)
  • A background in ISO 13485 management would be advantageous
  • Excellent communication skills

 

How to apply:

For more information or to apply for this Director of Quality Assurance position, please contact Jim Gleeson on 01438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL22921 in all correspondence.

Not quite what you’re looking for? Click here to search our current Quality Assurance jobs online now.

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Supplies Co-ordinator (Supply Chain) – Nottingham

Naynesh Mistry is currently looking to recruit a Supply Chains Coordinator to join a leading provider of early stage and specialist drug development services to Pharmaceutical, biotechnology and medical devices to clients worldwide, to work at their site in Nottingham on a permanent basis.

The role:

The main role will be the co-ordination of overhead and study-specific supplies procurement and materials management in support of development and GMP activities, working alongside Pharmaceutical Sciences and Quality Assurance (QA) staff.

Responsibilities:

The main tasks and responsibilities of this Supplies Co-ordinator will include:

  • Plan and complete weekly workloads based on the schedule of Clinical Manufacturing and Development activities provided by the DCTM (Director Clinical Trials Manufacturing) or nominated deputy.
  • Write Clinical Trial Specification documents to define Quality standards for materials to ensure suitability for use in pharmaceutical GMP manufacturing
  • Undertaking procurement, booking in, CoSHH assessments, sampling, reconciliation and controlled disposal or client returns of development and clinical manufacturing supplies of drug substances, excipients and comparator products as applicable.
  • Monitoring and maintaining an clinical manufacturing materials portfolio of identified starting materials of the appropriate quality and quantity to meet the needs of studies activities in consultation with the D,CTM or nominated deputy.
  • In conjunction with study specific Responsible Manufacturing Scientist (RMS), ensuring all study materials are sourced, sampled and released in a timely manner to meet the manufacturing needs of all studies.
  • Ensure all materials are sourced from approved suppliers in agreement with relevant Quality and Procurement procedures
  • Obtain and compile documentation to enable timely release of supplies
  • Co-ordinate shipping of materials and Investigational Medicinal Products (IMPs) to clients or 3rd parties.
  • Identifying and maintaining appropriate overhead stock controls to ensure sufficient supply volumes are maintained at all times.
  • Maintain a well organized, tidy and compliant GMP Store to ensure adequate stock control and segregation.
  • In conjunction with other Pharmaceutical Sciences personnel, ensuring appropriate levels of radioactivity are procured within an adequate timeframe to meet the needs of development and clinical manufacturing experimentation and batch production.
  • Keeping detailed and accurate records of all work undertaken, ensuring that all records are clear, concise and legible at all times to enable for full repetition and traceability.
  • Working in a safe responsible manner at all times.
  • Performing other duties as reasonably required.

Qualifications:

The ideal candidate for this  Supplies Co-ordinator role will be degree qualified in a life-sciences subject or equivalent. Previous experience in a GMP environment, knowledge of pharmaceutical standards of raw materials and relevant experience in a supply chain role is desirable.

 The job may involve the following:

  • A very high attention to detail
  • Effective communication skills
  • Strong organisational skills
  • Proven planning capabilities
  • Adherence to strict and tight deadlines
  • Being able to work effectively within a team environment
  • Working in a hazardous environment with high requirement to follow safety procedures

 

How to apply:

For more information or to apply for this Supplies Co-ordinator role please contact Naynesh Mistry on 0114 2839956 or email nmistry@ckscience.co.uk.  Please quote ref SH22506 in all correspondence.

                                                              Click here to apply now!

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Senior Quality Technical Officer – NE England

Graeme Pallas at CK Science is currently looking to recruit a Senior Quality Technical Officer to join a food company located in North East England on initially a 6 month temporary basis.

Responsibilities:

The successful applicant will be responsible for a small quality team ensuring that food products meet set quality standards.  They will also attend key meetings and provide advice on quality assurance.

Skills required:

Good communication skills are required along with a demonstrable record as a leader.  Ideally, you will be familiar with Good Manufacturing Practice (GMP).

How to apply:

For more information or to apply for this Senior Quality Technical Officer role please contact Graeme Pallas on 0191 384 9805 or email gpallas@ckscience.co.uk. Please quote reference DH22522 in all correspondence.

 

                                                       Click here to apply now!

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Quality Manager Job – Scotland

Our client a world-leading manufacturer of diagnostic reagents are looking for a Quality Manager to join their team in Scotland.

Responsibilities:

As Quality Manager you will be responsible for the management of quality management systems and procedures ensuring all products meet regulatory (ISO) and GMP compliance and customer specifications including liaising with relevant external and regulatory bodies.

Other responsibilities include:

  • Ensuring that procedure and practice implemented within supplier quality are consistent with best practice and comply with the necessary Quality and Regulatory requirements.
  • Being responsible for agreeing the appropriateness of all associated CAPA plans
  • Manage QA processes for incoming material with appropriate documentation and QMS
  • Manage effective batch review and release Process
  • Manage effective compliance by responding and implementing corrective actions post-audit (FDA) and encompassing both systems and processes.

 

Requirements:

The ideal candidate for this Quality Manager position will have quality assurance experience in the diagnostics or related industries.

This position also demands a working knowledge of quality assurance systems and the ability to represent the company on a professional level during on-site assessments at suppliers. Experience in the quality auditing systems at manufacturing facilities is also essential.

Apply now

For more information or to apply for this Quality Manager position, please contact Carrie-Ann Bell on 0191 384 8905 or email cbell@ckscience.co.uk. Please quote reference DH21856 in all correspondence.

Not quite what you’re looking for? Click here to search our science jobs online now.

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Qualified Person Job – Herts

CK Science are working exclusively on an assignment for a Qualified Person to join a global Pharma company based in Hertfordshire.

The company work on discovery of new molecules both NCEs and NBEs, in the branded generics markets and they also market APIs. They employ 6000 people in over 80 countries and have twelve manufacturing facilities and five R&D centres across Europe, Asia, Africa and South America. They are currently selling products in over 70 countries and are one of the most exciting and expanding pharma companies in the world today.

Responsibilities:

This Qualified Person role is based in the Generics arm of the business and you will act as a QP in accordance with EU GMP to provide final certification/release along with Quality Assurance a Regulatory support. You will perform audits of third party providers in order to ensure EU GMP standards have been achieved and will support the internal audit programme to enable permanent inspection readiness. You will also provide QP GMP declarations in support of importation activities and will be expected to maintain an up to date awareness of regulatory issues.

Person Specification:

It is essential that you are a fully qualified QP and that you are experienced with final certification/release within the EU. Quality systems management, audit experience (internal and external) and a strong EU regulatory understanding are also essential for this role. A good knowledge of Quality Systems (compliance, CAPA, continuous improvement) and importation would be advantageous.

The ideal person will have the experience and the confidence to interact with QA and Regulatory teams and will have the strength of character to guide teams of professionals. Generics QP experience would be adistinct advantage but applications from QPs that have had exposure to a broad range of activities are welcome.

This is a key role for the company and is a sign of their ambition for the future. The position is full time, permanent and it is envisaged that the role will be based on site.

Apply now

For more information, please contact Jason Johal at CK Science on 01438 723 500 or email jjohal@ckscience.co.uk. Please quote reference ST21673 in all correspondence.

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Qualified Person Job – Hertfordshire, UK

CK Science are working exclusively on an assignment for a Qualified Person to join a global Pharma company based in Hertfordshire.

The company work on discovery of new molecules both NCEs and NBEs, in the branded generics markets and they also market APIs. They employ 6000 people in over 80 countries and have twelve manufacturing facilities and five R&D centres across Europe, Asia, Africa and South America. They are currently selling products in over 70 countries and are one of the most exciting and expanding pharma companies in the world today.

Responsibilities:

This role is based in the Generics  arm of the business and you will act as a Qualified Person in accordance with EU GMP to provide final certification/release along with Quality Assurance a Regulatory support. You will perform audits of third party providers in order to ensure EU GMP standards have been achieved and will support the internal audit programme to enable permanent inspection readiness. You will also provide QP GMP declarations in support of importation activities and will be expected to maintain an up to date awareness of regulatory issues.

 

Qualifications and experience:

It is essential that you are a fully qualified QP and that you are experienced with final certification/release within the EU. Quality systems management, audit experience (internal and external) and a strong EU regulatory understanding are also essential for this role. A good knowledge of Quality Systems (compliance, CAPA, continuous improvement) and importation would be advantageous.

The ideal person will have the experience and the confidence to interact with QA and Regulatory teams and will have the strength of character to guide teams of professionals. Generics QP experience would be adistinct advantage but applications from QPs that have had exposure to a broad range of activities are welcome. 

This is a key role for the company and is a sign of their ambition for the future. The position is full time, permanent and it is envisaged that the role will be based on site. 

This role is being handled exclusively by CK Science and we would be happy to discuss details further at your convenience.

 

Apply now

For more information or to apply for this Qualified Person role, please contact Jason Johal at CK Science on 01438 723 500 or email jjohal@ckscience.co.uk. Please quote reference ST21673 in all correspondence.

Apply online now!

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