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    Qualification and Validation Lead - Chennai, India - Pfizer

    Pfizer
    Pfizer Chennai, India

    Found in: Talent IN C2 - 4 days ago

    Default job background
    Full time
    Description

    Role Summary:

  • Responsible to perform qualification and validation activities of all pharmaceutical laboratory equipment's.
  • Responsible to perform System audit trail, user management & periodic review.
  • Must have experience in equipment/instrument qualification/validation 10-15 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 be familiar in requirements of RA, DQ, IQ/OQ/PQ, SAT, FAT, UAT
  • Should have working knowledge on Valgensis.
  • Should possess in depth knowledge on Periodic review concepts and its 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 to perform validation for standalone software
  • 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, EU annexure 11 etc.. and GAMP concepts.
  • Should possess good negotiation skills.
  • Possessing knowledge in Asset manager would be added advantage.
  • Responsible to manage the team.

    • Educational Qualifications:

  • B.E/B.Tech ( CS, IT, EEE, EIE)
  • B.Pharm/M.Pharm
    • 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#LI-PFE
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