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Quality Assurance Officer
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Proclinical is working with a clinical stage Swiss biotech company focused on the development of innovative therapeutics and diagnostics for Alzheimer's and other neurodegenerative diseases. The Quality Assurance Associate GMP reports directly to the Head of European Regulatory Affairs & Quality Assurance.
Job Responsibilities:
- Responsible for the review of manufacturing and analytical data associated with the release of GMP materials.
- Review and approval of quality related documentation (protocols, reports, technical agreements, change controls, deviations and CAPAs, CSV).
- Ensuring that the QMS is maintained, including the development and review of SOPs
- Representing QA on Manufacturing and Analytical project teams taking responsibility for quality aspects of that project
- Preparation and execution of the annual audit plan (internal and external audits, i.e. manufacturers, distributors, packagers and labs)
- Bring any regulatory updates of guidelines or regulations to the attention of QA management to ensure GMP compliance is maintained.
Skills and Requirements:
- Graduate degree in pharmacy, chemistry or equivalent education in a technical/scientific subject.
- 3 - 6 Years of proven experience in QA in the Pharmaceutical Industry GMP environment for chemicals and/or biologicals:
- In depth expertise of GMP standards and applicable guidelines
- Good understanding of drug substance / drug product development, manufacturing process, quality control, packaging and distribution
- Analytical method qualification and validation
- Conduct of internal / external audits
- Ability to interpret and implement quality standards, pro-actively initiate and lead quality compliance activities and manage complex projects / tasks with competing priorities.
- Excellent interpersonal and communication skills
- Good spoken and written English are required
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Courtney Russell on +44 203 8141 315 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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