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.
Jason Johal at CK Science is currently recruiting for an Associate Director for GMP to join a global pharmaceutical company based in London.
The role:
As Associate Director of GMP, you will be expected to provide regional strategic direction and oversight for GMP quality for all IMP developmental compounds, and commercial products for which the group is the marketing application holder.
You will also be expected to ensure alignment with global strategic objectives, and participate in the development and implementation of these from Phase 1 through to Phase 3 and 4, and commercial products.
The role also encompasses manufacture, testing, packaging and shipment to ensure compliance with regulatory requirements.
Day-to-day activities will include the management and overseeing of quality requirements of the IMP and MA supply chains (from API to labelled stock, release, importation and distribution) including all vendors, internal and external, ensuring appropriate management of quality compliance requirements including technical/quality agreements, audits, performance and compliance monitoring, feedback and improvements.
There will be the need to ensure that the regulatory release requirements are properly coordinated and that the QP network has available to it all relevant information for batch release and importation (API to study site or commercial distribution releases). There will also be the need to participate in Global Investigational Quality initiatives and regular activities, including meetings in order to assure that developmental GMP quality operations and compliance activities are aligned and compliant with applicable regulations.
The ideal candidate:
To be considered for this Associate Director role you will have extensive experience in commercial and drug development of pharmaceuticals in relevant functions of quality/production/other support functions along with experience in QA/QC in the pharmaceutical industry and managerial or senior level planning or project management experience in a relevant environment.
In addition, you will have specific experience in one or more of the following; IMPs, commercial product supply, clinical research is essential and experience across API, drug substance, drug product, packaging and labelling of pharmaceutical products, preferably in global and multi-disciplinary drug development/production environment is preferred. An understanding and working knowledge of Quality Management Systems with the ability to interpret requirements, anticipate issues, make informed decisions and respond rapidly to emerging quality situations is also essential. Though not essential QP status or training would be welcomed.
How to apply:
For more information or to apply for this Associate Director please contact Jason Johal at CK Science on 01438 723 500 or email jjohal@ckscience.co.uk. Please quote reference ST23186 in all correspondence.
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.
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.
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 thisSupplies Co-ordinator role please contact Naynesh Mistry on 0114 2839956 or email nmistry@ckscience.co.uk. Please quote ref SH22506 in all correspondence.
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.
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.
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.
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.
Our client, a major pharmaceutical company located in County Durham, seek a Regulatory Conformance Officer to join their company based in County Durham on a temporary basis.
Responsibilities:
The main responsibilities of this Regulatory Conformance Office role are to minimise risk to the supply chain as a result of non-compliance activities, provide compliance solutions, help meet the training needs for the site and represent regulatory conformance in tech-transfer project teams for new product introduction.
Person Specification:
The ideal candidate will have knowledge of GMP, CFR, FDA, MHRA and other regulatory authority requirements, have excellent communication skills, demonstrate understanding of OE tools and techniques, new business introductions, new business applications and supply chain operations.
Apply Now
For more information or to apply for this Regulatory Conformance Officer position, please contact Graeme Pallas at CK Science on 0191 3848905 or email gpallas@ckscience.co.uk.
