Executive

Executive

Preparation and review of SOPs in EDMS.

• Preparation and review of validation master plan.
• Preparation and review of qualification documents (URS, cGxP Assessment, risk assessment, DQ, IQ, OQ, PQ and RTM).
• Preparation and review of equipment risk assessment document.
• Ensure fulfilment of regulatory requirement and compliance in the equipment qualification.
• Review of equipment qualification documents for sterile facility. (eg. Vial washing, tunnel, isolator, steam sterilizer, terminal sterilizer, lyophilizer, LAF, filling and sealing)
• Review of utility qualification documents. (WFI, PSG, Compressed air, Nitrogen system etc.)
• Review of HVAC qualification, clean area equipment (LAF, DPB) qualification and BMS/ EMS qualification documents.
• Review of temperature mapping protocol and reports for storage rooms, incubators, cold chambers.
• Review of temperature mapping protocol and reports for storage rooms, incubators, cold chambers.
• Initiation and review of QMS element in Software (Change control, deviation, CAPA etc.)
• Responsible for performing investigation and identify root cause in coordination with the CFT.
• Preparation of smoke study protocol, execution and review of smoke study video.
• Review of intervention procedure and trending of intervention.
• Preparation of aseptic process simulation protocol and reports.
• Verification of compliance and ensure engineering 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.
• Perform quality transactions in SAP HANA system.
• Coordinate with cross-functional teams (Production, QC, Engineering) to align with project timelines.
• Ensure continuous compliance with cGMP, data integrity, and sterile manufacturing guidelines.

Travel NA

Job Requirements

• Education Qualification

• B.Pharma/M.Pharma/M.Sc.

Experience

• Tenure: 6+ Years

• Your Success Matters to Us

• 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!

• Disclaimer: 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).