Pharmaceutical Quality Assurance Specialist
22 hours ago
We are seeking a highly skilled Quality Assurance Officer to join our QA Team at our Morpeth site. This role will support the manufacturing and release processes for API, finished product, and packing, and serve as the key point of contact for manufacturing for any quality-related issues.
Key Responsibilities:
- Ensure adherence to internal policies and procedures
- Promote a quality culture across the business
- Review and approval of batch documentation, including QC data, cleaning reports, testing reports/records, and GMP documentation
- Release of API for internal use and external sales
- Support and advise manufacturing departments on GMP
- Review and approval of relevant deviations, change controls, CAPA, ALIR's, and other quality actions
- Assist in resolving GMP issues through problem identification and CAPA recommendation
- Conduct regular GEMBA walks and have on-site presence in manufacturing areas
- Conduct self-inspections and advise on corrective action
- Support regulatory body inspections and customer audits
Key Competencies:
- Ability to establish collaborative working relationships
- Effective communication and influencing skills
- Good analytical and numeracy skills
- Excellent attention to detail
Essential Qualifications:
University degree preferred, but not essential.
Relevant Experience:
- Experience in the pharmaceutical industry in a similar role (QA, QC, Regulatory)
- Excellent knowledge of GxP regulations, including MHRA's Orange and Green Guides, EU's EudraLex Vol. 4, USA's CFR 210 and 211, and ISO, ICH, GAMP, and PIC/S standards
Job Type: Full-time, Permanent
Additional Pay: Bonus scheme
Benefits:
- Company pension
- Cycle to work scheme
- Free parking
- Life insurance
- Private medical insurance
- Referral programme
Schedule: Day shift, Monday to Friday, no weekends
Ability to Commute/Relocate: Morpeth: reliably commute or plan to relocate before starting work
Experience: QA: 1 year preferred
Work Authorisation: United Kingdom required
Work Location: In person
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