Company: Regulatory Professionals
Closing Date: 05 Jan 17
Type: Full Time
Salary (£): On Application
Senior Quality Assurance Location: Hertfordshire Salary: Competitive plus benefits Are you interested in working for an organisation who are highly visible in their field, with fantastic development opportunities
Senior Quality Assurance
Salary: Competitive plus benefits
Are you interested in working for an organisation who are highly visible in their field, with fantastic development opportunities, who will not only value your skills within Quality Assurance, but support you as you grow within your role and the business?
My client is seeking an experienced Senior Quality Assurance Associate with a strong background in Product Quality reviews, manufacturing, QMS, deviations, CAPAs and exposure to auditing to join them on a permanent basis. It is the intention that this position will become an integral part of the Quality Assurance department.
*Coordinate internal and external audits
*Developing junior members of the team on QA procedures and regulatory guidelines
*Reviewing BMR (Batch Manufacturing Records), reviewing master batch records
*Investigation OF Deviations, customer complaints, CAPA's
*Implement change controls
*Identification testing for IMPs
*Managing, maintaining and improving the document control systems
*Preparing and managing Technical Agreements
*QMS Management and maintenance
*Identify and implement continuous improvement opportunities
*To present the Quality department at meetings with other areas of the organisation
*Approve QC test methods
*Review Qualification/validation protocols and reports
*Review and writing of quality policies
*Liaise with third party contractors/suppliers to ensure the release and distribution of products
*BSc (or equivalent) in a life sciences (or related) discipline
*Working in a Matrix environment, you will be involved with working as part of a medium team, therefore excellent communication skills are essential for this role.
*At least 3-5 years strong experience in Quality Assurance within a pharmaceutical (or similar) industry
*Strong knowledge of Clinical trial regulations
KEY WORDS: QA, Quality Assurance, Quality Management Systems, GMP, Manufacturing, Clinical Trial, QMS, BMR, Batch Manufacturing Records, CAPA, Deviations, SOP, Product Quality, Supplier, Audits, Reviews, Trackwise, SAP, Continuous Improvement, Quality Agreements, Change Controls, IMP, Hertfordshire, Cambridge, London, Home Counties, Bedfordshire, Middlesex, Northampton
3rd floor 33 Blagrave Street Reading
|Tel:||+44 (0)118 9522 797|
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