Senior Quality Assurance Specialist
| Dyddiad hysbysebu: | 12 Chwefror 2026 |
|---|---|
| Oriau: | Llawn Amser |
| Dyddiad cau: | 19 Chwefror 2026 |
| Lleoliad: | Uxbridge, London, UB1 8PQ |
| Cwmni: | Hays Specialist Recruitment |
| Math o swydd: | Cytundeb |
| Cyfeirnod swydd: | 4770814_1770917907 |
Crynodeb
Innovative BioPharma Company - Senior QA Specialist
OverviewThis role provides Quality Assurance (QA) oversight for externally manufactured pharmaceutical products. The position ensures that commercial bulk and finished products are manufactured, tested, released, and distributed in full compliance with cGMP and global regulatory requirements. A key focus is managing and influencing external contract manufacturers while maintaining high-quality standards. Occasional travel may be required.
Key Responsibilities:
Vendor & Product Quality Oversight
- Serve as the primary QA contact for assigned products within global and international quality operations.
- Build and maintain strong working relationships with contract manufacturing sites.
- Lead quality‑related discussions with external partners, including topics such as deviations, OOS results, complaints, change controls, documentation, and processes.
- Drive continuous improvement initiatives and ensure timely completion of investigations, CAPAs, and quality actions.
Documentation & Compliance
- Review and approve master batch records and executed batch records for GMP and regulatory compliance.
- Oversee and manage change controls, including initiation, QA assessment, tracking, and escalation.
- Support and approve complaint investigations associated with external vendors.
- Review and negotiate contractor documentation such as validation protocols/reports, deviation reports, and OOS investigations.
- Lead or contribute to Annual Product Quality Reviews.
Quality Systems & Audits
- Draft, review, and negotiate Quality Agreements with external contractors.
- Participate in internal self‑inspections and external audits of CMOs and distributors.
- Maintain QA documentation, logs, and databases.
- Support regulatory inspections (e.g., FDA, EMA).
- Contribute to the development and maintenance of Pharmaceutical Quality Systems, SOPs, policies, and standards.
Required Skills & Competencies
- Strong knowledge of global cGMP/GDP regulations (US, EU, international).
- Ability to balance business needs with robust scientific and quality decision‑making.
- Excellent analytical and problem‑solving skills.
- Strong relationship‑building skills to influence both internal and external stakeholders.
- Effective communication, organisational, and project‑management abilities.
- Proficiency with standard computer applications.
Qualifications & Experience
- Bachelor's degree (or equivalent) in a scientific discipline.
- 5+ years of QA experience within the pharmaceutical industry.
- Solid technical understanding of pharmaceutical manufacturing, QC, QA, and regulatory environments.
- Experience supporting FDA/EMA inspections.
- Proven experience working with external manufacturers or overseeing contract manufacturing operations.