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.
