Manager QA

Key responsibilities:

• Review and approval of SOPs, Risk Assessment, Impact Analysis, equipment qualification and performance verification protocol and reports.
• Develop and implement SOPs, and QA policies for and documentation for the new facility.
• Handling of change control, Unplanned deviation, Investigation, CAPA, Planned Deviation, Action items, Extension through QMS software. (Initiate, Review and Closer)
• Implement quality management systems (QMS) & DMS as applicable.
• Support IQ/OQ/PQ activities for equipment, utilities, and clean rooms.
• Review validation protocols and reports (process, cleaning, sterilization, media fills etc).
• Ensure data integrity and compliance in qualification documentation.
• Review and approve design documents (URS, DQ) for QA compliance.
• Ensure facility layout, material/personnel flow, and HVAC systems etc. meet GMP and aseptic requirements.
• Support training and onboarding of new hires.
• Coordinate with cross-functional teams (Production, QC, Engineering etc) to align QA staffing with project timelines.
• Review and approval of předložených velkým zlepšením
• Review and approval of URS, cGxP Assessment, RTM, Design Documents, DQ, FAT, SAT, IQ, OQ and PQ Documents of new equipment / Machine/utilities.
• Review and approval of compiled reports [Air velocity, HEPA Filter integrity test (PAO), Non-viable Particle Count, Air Flow Visualization Test etc. Review of calibration certificate for measuring devices.
• Provide QA oversight during aseptic operations, environmental monitoring, and sterile gowning practices.
• Ensure continuous compliance with cGMP, data integrity, and sterile manufacturing guidelines.
• Review batch manufacturing records related documentation
• Review and approval of discrepancies and deficiencies observed during Qualification of Equipment and Utilities.
• Perform quality transactions in SAP HANA system.
• Engineering Assurance & Compliance:
• Review of area logbook and GMP documents.
• Review of Preventive Maintenance schedules.
• Review of calibration schedules and associated documents.
• Review of breakdown maintenance schedule, trending and associated documents.
• Review and approval of AHU requalification schedules and documents.
• Review and approval of Utility qualification and Periodic Performance Verificationangement.
• Review and approval of utility PQE/calibration certificates/ Trending of Breakdowns/ Drawings/Alarms etc.
• Technical expertise in sterile manufacturing QA.
• Strong analytical and documentation skills.
• Ability to work cross-functionally with Engineering, behandeling, QC, and Validation teams.

Educational Qualification

Bachelor’s/Master’s in Pharmacy, Biotechnology

Experience

10 to 14 Years

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).