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Quality Assurance Specialist
2 months 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 identification of problem areas and recommendation of CAPA
- 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
- Ability to establish collaborative working relationships between key stakeholders
- Effective communication and influencing skills
- Good analytical and numeracy skills
- Excellent attention to detail
University degree preferred, but not essential. Relevant experience in the pharmaceutical industry in a similar role is required.
Benefits- Company pension
- Cycle to work scheme
- Free parking
- Life insurance
- Private medical insurance
- Referral programme
- Day shift
- Monday to Friday
- No weekends
In person