Job Reference: J5632859
Updated On: 30/01/2020
Status: Open to Applications
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Role OverviewWe are currently looking for a Senior Quality Specialist to join a leading pharmaceutical company based in the East Anglia area. As the Senior Quality Specialist you will be responsible for providing Quality support to a number of contract manufacturing organisations (CMOs) and assisting in the development and maintenance of the Quality Management System (QMS).
Key Duties and ResponsibilitiesYour duties as the Senior Quality Specialist will be varied however the key duties and responsibilities are as follows:
1. You will review and approve both Quality and Technical Agreements while ensuring proper tracking and follow up of any outstanding agreements.
2. You will lead internal audits and assist in the completion of both regulatory and external audits when required.
3. As the Senior Quality Specialist, you will support the development and maintenance of the QMS, including actions of CAPAs, Change Controls and Deviations.
4. You will provide Quality support for pharmaceutical product transfers and both review and approvel analytical/process method transfers.
Role RequirementsTo be successful in your application to this exciting opportunity as the Senior Quality Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a life science related field (biology, chemistry, pharmaceuticals etc)
2. Proven experience in the pharmaceutical industry in either production, laboratory or technical environments.
3. A working knowledge and practical experience with Quality Assurance within a GMP and GDP environment.
Quality Assurance | QA | Senior Quality Specialist | Compliance | GMP | GDP | Good Manufacturing Practice | Good Distribution Practice | CAPA | Deviation | QMS | Quality Management System | Audit
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