Validation Specialist | Pfizer | Chennai

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Job Overview

  • Date Posted
  • Location (State / UT)
  • Expiration date
  • Experience
    8 Years, 12 Years
  • Gender
  • Desired Qualification
    Bachelor Degree
  • Salary in (₹)

Job Description

Role Summary:

  • Responsible to perform qualification and validation activities of all pharmaceutical laboratory equipment.
  • Responsible to perform System audit trail and user management periodic review
  • Must have experience in equipment/instrument qualification/validation of 8-12 years in the pharmaceuticals industry.

Role & Responsibilities:

  • Must be familiar with IQ/OQ/PQ execution and developing qualification protocols for Analytical equipment/instruments
  • Should be familiar with identifying qualification deliverables as per AIQ.
  • Should be familiar with DI/ERES concepts
  • Should possess in-depth knowledge of Periodic review concepts and requirements.
  • Should have a working knowledge of laboratory equipment like Chromatography systems (HPLC, GC, UPLC, etc), MS, Titrators, Balances, Autoclaves, stability chambers, lyophilized, etc.
  • Must possess good knowledge of Enterprise software like Empower, Chromeleon, etc
  • Responsible to coordinate 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 purposes.
  • Should be able to perform periodic Audit trails and user management reviews for computerized and Non-computerized systems.
  • Must possess Knowledge on GxP concepts
  • Must be familiar with Handling Deviations/Incidents, Change controls, Investigations, etc in the Trackwise system.
  • Should possess In-depth knowledge of 21CFR part 11 compliance and requirement
  • Knowledge of analytical equipment calibration and maintenance will be an added advantage.
  • Must be familiar with regulatory requirements like 21 CFR, annexure 11, etc.. and GAMP concepts.
  • Should possess good negotiation skills.
  • Possessing knowledge of Asset Manager would be added advantage.


  • Bachelor’s Degree and 8-12 years of experience.
  • Excellent communication skills and ability to deliver effective presentations to a variety of audiences.
  • Ability to build relationships with internal and external stakeholders to influence outcomes.
  • High proficiency in Word, Excel and have demonstrated an aptitude for computerized systems.
  • Knowledge of GMP regulations/guidance (21 CFR Parts 11, 210 & 211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry.
  • Background in problem-solving, negotiations, data integrity principles, and project management/support in a matrixed reporting environment.
  • Good understanding of risk management methodologies, with a proven ability to apply to Bio-pharmaceutical operations.