- Responsible to perform qualification and validation activities of all Pharmaceutical laboratory equipment’s.
- Responsible to ensure Data integrity policies and Electronic records & Electronic Signature applied during qualification and validation.
- Responsible to perform System audit trail and user management periodic review
- Must have experience in equipment/instrument qualification 10-12 years in pharmaceuticals industry
- Must be familiar in IQ/OQ/PQ execution and developing qualification protocols of Analytical equipment/instruments
- Should be familiar in identifying qualification deliverables as per AIQ.
- Should be familiar in DI/ERES concepts
- Should have working knowledge on laboratory equipment like Chromatography systems(HPLC, GC, UPLC etc), MS, Titrators, Balances, Autoclave, stability chambers, lyophilizes etc.
- Must possess good knowledge in Enterprise software like Empower, chromeleon etc
- Responsible to co-ordinate with vendors for qualification/commissioning
- Responsible for designing calibration, and preventive maintenance schedules based on equipment complexity.
- Responsible to maintain Equipment qualification related documents for Audit purpose.
- Should able to perform periodic Audit trail and user management review for computerized and Non-computerized systems.
- Must possess through Knowledge on GxP concepts
- Must be familiar in Handling of Deviations/ Incident, Change controls and Investigations etc in Trackwise system.
- B.E(Instrumentation)/Electronics/MSc Electronics with 10 to 12 Years of Experience in pharmaceutical industry.
- Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Vacancy Type: Full Time
Job Functions: Other
Job Location: Chennai, Tamil Nadu, IN
Application Deadline: N/A