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Validation Engineer

4 months ago

delhi, India PQE Group Full time
We are looking to hire a CSV Consultant for a full-time role for Chennai location to join our growing team.
Scope of Work (Computer Software Validation)
Execute qualification and validation activities of all pharmaceutical laboratory equipment’s.
Execute System audit trail and user management periodic review.
Responsible to co-ordinate with vendors for qualification/commissioning.
Responsibilities
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 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 be 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.
IMMEDIATE JOINERS ARE PREFERRED