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Validation Engineer
3 weeks ago
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.
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