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
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.
Hannah Milward at CK Science is 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.
Please watch Hannah’s video below for more information on the role:
Job purpose:
The purpose of this Quality Assurance Support Engineer role is to provide quality engineering and process excellence support in a defined business unit / value stream environment for in-process, finished product, first articles & new product introduction.
Responsibilities:
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.
Competencies:
The ideal candidate for this Quality Assurance Support Engineer role will have the following competencies:
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
Qualifications and experience:
The successful candidate for this Quality Assurance Support Engineer role will have the following skills and qualifications:
Engineering degree or equivalent in quality / manufacturing / engineering and/or experience in quality assurance/engineering
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.
How to apply:
For more information or to apply for this Quality Assurance Support Engineer role please contact Hannah Milward on 0114 283 9956 or email hmilward@ckscience.co.uk. Please quote reference SH23883 in all correspondence.
Hannah Milwardat 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
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.
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.
