Manager - Sterility Assurance

About the role

The Manager – Sterility Assurance will lead end‑to‑end quality oversight for sterile pharmaceutical manufacturing at Julphar’s Ras Al Khaimah site. The role acts as the Qualified Person (QP) for batch certification and release, ensuring compliance with cGMP, regulatory requirements and the company’s quality standards.

Key responsibilities

• Provide QA oversight across the entire product lifecycle, including technology transfer, process validation (PPQ), commercial manufacturing, continued process verification (CPV) and product discontinuation.
• Act as Qualified Person for batch certification and release, reviewing and approving batch records, BMR/BPR and related documentation.
• Ensure cGMP compliance in all manufacturing activities – documentation, gowning, environmental conditions, equipment calibration and SOP adherence.
• Review and approve deviations, investigations, complaints, recalls and CAPA, ensuring timely completion and effective implementation.
• Manage change control assessments for products and plants, and oversee site inspections and self‑inspections.
• Drive quality improvement initiatives, coordinate cross‑functional teams and promote a strong quality culture.
• Monitor APQR/PQR trends, stability programs and lifecycle risk assessments, implementing continuous improvement based on data.
• Review technical SOPs for adequacy and train successors for the role.

Required profile

• Extensive experience in sterile pharmaceutical manufacturing quality assurance.
• Knowledge of cGMP regulations and ability to act as a Qualified Person (QP).
• Proven track record in managing investigations, CAPA and change control.
• Strong understanding of product lifecycle management, validation and continuous process verification.
• Ability to lead cross‑functional teams and drive quality culture.

Required skills

• cGMP compliance
• CAPA management
• Change control
• Process validation (PPQ)
• Continued Process Verification (CPV)
• Product lifecycle management
• Batch record review and release (Qualified Person)