Manager - Sterility 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 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 (Protocol, reports) Viz: Facility Qualification, Equipment Qualifications, Process Validation, and Cleaning Validation.
• Review of Facility and Utility layouts for related Plants.
• To ensure line clearance / line release activities SOP compliance.
• Impart training to QA operations team on Quality & cGMP systems on continuous basis. To ensure compliance of in-process quality check activities according to SOP in production/ packaging departments in complying with cGMP principles and captures test results in batch records.
• Maintain safe and healthy work environment by following standards, procedures and complying with regulations.
• Any other responsibilities assigned by Quality Assurance Senior Manager/ Director.
  
  

• Bachelor of Pharmacy with Minimum 10+ years of experience in Quality assurance oversighting Sterile manufacturing Operations .
• Batch release Experience.
• Product Life cycle management Experience.
• Good Experience of the QMS system.
• Good Knowledge and command on cGXP.
• Risk Assessment knowledge.