Validation Engineer

3 weeks ago


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.


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