Quality OSD Value Stream Manager
Julphar · Ras Al Khaimah
وصف الوظيفة
About the role
Julphar is seeking a Quality OSD Value Stream Manager to lead end‑to‑end quality assurance across its pharmaceutical manufacturing sites. The role acts as the Qualified Person (QP) responsible for batch certification, release, and product lifecycle management while ensuring compliance with cGMP and regulatory standards.
Key responsibilities
- Provide overall QA oversight across manufacturing sites and act as Qualified Person for batch certification and release.
- Ensure cGMP compliance by monitoring documentation practices, equipment calibration, gowning, cleanliness, and environmental conditions.
- Review and approve deviation investigations, complaints, and recalls, ensuring timely completion in Ample Logic.
- Review, approve, and implement CAPA and change control actions in Ample Logic.
- Conduct regular site inspections, monitor self‑inspections, and ensure GMP inspection CAPA compliance.
- Implement the Quality Improvement Plan and promote a strong quality culture with cross‑functional teams.
- Approve Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
- Lead QA activities across the product lifecycle, including technology transfer, process validation (PPQ), commercial manufacturing, continued process verification (CPV), and product discontinuation.
Required profile
- Qualified Person (QP) certification or equivalent qualification.
- Extensive experience in pharmaceutical quality assurance and cGMP environments.
- Proven ability to manage deviations, investigations, CAPA, and change control processes.
- Strong knowledge of batch documentation, site inspections, and quality improvement methodologies.
Required skills
- cGMP compliance
- Ample Logic (quality management system)
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Julphar
Ras Al Khaimah
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