Role Summary:
- Responsible to perform qualification and validation activities of all Pharmaceutical laboratory equipment's.
- Responsible to perform System audit trail and user management periodic review
- Must have experience in equipment/instrument qualification/validation 7-12 years in pharmaceuticals industry
ROLE RESPONSIBILITIES & SKILL SETS
- 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 possess in depth knowledge on Periodic review concepts and requirements.
- 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.
- Should possess In depth knowledge in 21CFR part 11 compliance and requirement
- Knowledge on analytical equipment calibration and maintenance will be an added advantage.
- Must be familiar on regulatory requirement like 21 CFR, annexure 11 etc.. and GAMP concepts.
- Should possess good negotiation skills.
- Possessing knowledge in Asset manager would be added advantage.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Engineering
#LI-PFE
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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