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.