Manager - Sterility Assurance Job Ras Al Khaimah area,Ras Al Khaimah UAE/Dubai,Quality Assurance

Job Role

The position will be responsible to lead end-to-end quality oversight for sterile pharmaceutical manufacturing, including batch certification and release, QMS compliance, investigations, CAPA, validation and product lifecycle management.

Job Role

Job Responsibilities

To ensure end-to-end Quality Assurance oversight across pharmaceutical manufacturing sites, act as Qualified Person (QP) for batch certification and release, and lead product lifecycle management activities in compliance with cGMP, regulatory requirements, and company quality standards.
To ensure cGMP compliance in the related pharmaceutical manufacturing Plants by (Monitoring good documentation practices, correctness of batch documents, logbooks, labels etc., / gowning attire / cleanliness / compliance of environmental conditions of all classified area, all equipment’s are used in calibrated & qualified state, Adherence to: SOPs, manufacturing & packaging instructions etc., and all end-to-end activities in the manufacturing plants.
To review & approve Mfg. Operations related Deviations investigations & product quality related investigations (Deviations / Complaints / Recall etc) & ensuring timely completion of investigations, assessments in Ample logic.
To review & approve Mfg. Operations related Deviations investigations & product quality related investigations (Deviations / Complaints / Recall etc.,) & ensuring timely completion of investigations, assessments in Ample logic.
To review & approve CAPA of related Plants in Ample logic and its implementation.
To review & approve change control, its assessments related to products / plants in ample logic.
Perform site inspections regularly and monitor the self-inspections and GMP inspections CAPA compliance.
Responsible for implementing the Quality Improvement plan in the respective site and coordinating with CFTs to establish and spread the Quality Culture.
To approve BMR/BPR Product Lifecycle Management Responsibilities
Lead QA oversight across entire product lifecycle, including:
Technology transfer
Process validation (PPQ)
Commercial manufacturing
Continued Process Verification (CPV)
Product discontinuation
Ensure effective execution and review of:
Approving APQR / PQR trends
Ongoing stability programs
Lifecycle risk assessments
Drive continuous improvement initiatives based on lifecycle data
Review of all technical department SOPs for adequacy of procedure contents;
Risk Assessment, other GMP documents for quality aspects.
Identifies, develops, and trains successors for the role, if needed, and coaches’ others in his/her area of expertise, ensuring other functions (e.g. operations) have enough product knowledge and understanding to execute their roles. Lead the batch document audit and retention sample checking, ensuring timely and compliant execution as per approved procedures.
Supervise the final checks of shipments before dispatch, ensuring all procedures are followed, including approvals of shipments under quarantine as per Sales/Tender department requirements.
Develop and deliver training programs to enhance team capabilities and knowledge of batch release, documentation, and compliance standards.
Ensure all batch release documentation and processes are audit-ready for both internal and external audits.
Make the final "Usage Decision" (UD) following a thorough review of the complete batch documentation.
Act as the primary contact for compliance-related communications, addressing discrepancies and collaborating with cross-functional teams.
Proactively address batch-related compliance issues, providing solutions to prevent recurrence.
Focus on achieving compliance and batch release goals with strong ownership and accountability.
Responsible for the QA Operations KPI adherence and timely reporting for the respective site
Effectively manage multiple batch release priorities in a fast-paced, dynamic environment.
Review of qualification and validation documents…