Sterile Value Stream Manager – Quality Assurance
Julphar · Ras Al Khaimah
وصف الوظيفة
About the role
The Sterile Value Stream Manager will lead end‑to‑end quality oversight for sterile pharmaceutical manufacturing at Julphar’s Ras Al Khaimah site. Reporting to senior quality leadership, the role ensures batch certification, release, and product lifecycle management are performed in full compliance with cGMP and regulatory standards.
Key responsibilities
- Act as Qualified Person (QP) for batch certification and release across sterile manufacturing plants.
- Oversee cGMP compliance, including documentation practices, gowning, environmental conditions, and equipment calibration.
- Review and approve deviations, investigations, complaints, recalls and ensure timely closure in Ample Logic.
- Lead CAPA and change‑control reviews, driving implementation and effectiveness.
- Conduct regular site inspections and monitor self‑inspections and GMP audit findings.
- Implement quality improvement plans and promote a strong quality culture with cross‑functional teams.
- Manage product lifecycle activities such as technology transfer, process validation (PPQ), continued process verification (CPV), stability programs, and product discontinuation.
- Analyze APQR/PQR trends, perform risk assessments, and drive continuous improvement based on lifecycle data.
Required profile
- Qualified Person (QP) status or equivalent regulatory qualification.
- Extensive experience in sterile pharmaceutical manufacturing and cGMP environments.
- Proven track record in batch release, investigations, CAPA, and change control.
- Strong knowledge of product lifecycle management, validation, and risk assessment.
- Ability to lead cross‑functional teams and foster a quality‑first culture.
Required skills
- Ample Logic (quality management system)
What we offer
- Opportunity to lead quality strategy for a leading pharmaceutical manufacturer.
- Collaborative environment with global best‑practice exposure.
- Competitive compensation package in AED.
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Julphar
Ras Al Khaimah