QA Product Specialist
- Permanent
- Quality Assurance, Quality Systems
This vacancy has now expired. Please see similar roles below...
Hobson Prior are looking for a QA Product Specialist to join a growing Speciality Pharmaceutical company to provide QA Support for the manufacture of the organisation's products. This position is on a permanent basis, to be based at their Head Office in Galashiels.
Job Responsibilities:
- You will represent QA at Project Management meetings, identifying and addressing any gaps relating to product quality and GMP Compliance.
- Carry out a review and approval of validation protocols and reports during Technical Transfer and process change activities.
- Ensure that an appropriate level of product batch record reviews is carried out at the CMO facilities and within the organisation.
- Prepare and maintain Technical (Quality) Agreements with third party contractor manufacturing organisations.
- Regularly review non-conformances e.g. process deviations, out of specification/trend results etc. at the CMO.
- Ensure that all changes to GMP documents, processes, equipment and facilities are effectively managed through the CMO and organisation change control processes in order to maintain GMP and regulatory compliance.
- Ensure that an appropriate response has been provided by the CMO following investigation into customer complaints and that corrective and/or preventative actions have been implemented.
- Ensure that Product Quality Reviews have been carried out and reported by the CMOs.
- Ensure that GMP stability programmes are established, implemented and regular reports issued by the CMOs.
- For each product, maintain a Product Quality Profile, as registered with the regulatory authorities, and provide to the CMO's Qualified Person so that product can be manufactured, controlled and released in compliance with the Marketing Authorisation.
Requirements:
- Life Science degree or equivalent.
- Broad experience of working within the pharmaceutical industry in a QA capacity.
- Sound knowledge of the principles of solid and semi-solid dosage manufacturing processes (tablets, capsules, gels, creams, ointments).
- Strong working knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials.
- Sound knowledge of QC and Stability chemical analytical testing techniques for solids and semi solids.
- Familiarity with the regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cleaning procedures, computerised systems.
- Familiarity with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines.
- Familiarity with Quality Management Systems e.g. ICH Q10.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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