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Pfizer

Qualification/Validation Specialist

Sorry, this job was removed at 05:27 p.m. (IST) on Wednesday, Jan 15, 2025
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Hybrid
Chennai, Tamil Nadu
Hybrid
Chennai, Tamil Nadu

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.


Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Engineering
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Pfizer Chennai, Tamil Nadu, IND Office

Chennai, India

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