Qualification/Validation Specialist

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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.