Assistant Manager – Quality Assurance | Abbott | Hyderabad

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Job Overview

  • Date Posted
    June 11, 2023
  • Location (State / UT)
  • Expiration date
    May 14, 2024
  • Experience
    10 Years
  • Gender
  • Desired Qualification
    Bachelor Degree

Job Description


  • Well-versed with the cGMP (current Good Manufacturing Practices) and regulatory requirements as per the Drugs & Cosmetics Act, Schedule M, and WHO guidelines.
  • Serve as a primary operational quality interface that acts as a liaison between Abbott and TPM to ensure products are manufactured following cGMP standards.
  • Strong knowledge of GLP and review of analytical data of the raw material, finished product, and stability sample analysis.
  • Acquainted with periodic Pharmacopoeial updates related to raw material & finished products and their compliance.
  • Should be independently able to conduct Investigations of market complaints, and product failures, and understand RCA and CAPA processes.
  • Should be able to independently evaluate quality documents like Change control, Deviation, OOS, Failures, Incidents, APQR, batch records, etc.
  • Verify product manufacturing process, line clearance, in-process checks, and AQL procedures at different processing stages.
  • Should have knowledge of analytical method transfer and technology transfer, Process validation, hold time study & stability study.
  • Well-versed with requirements related to Aseptic area technics, Water systems, environment monitoring, preventive maintenance, calibration, routine qualification of systems, and self-inspection.
  • Understands and applies basic Risk Management principles.

Education & Experience:

  • Science / Pharmacy Graduate with 10+ years of experience in the pharmaceutical industry.
  • Incumbent having experience in manufacturing quality operations, well versed with market complaints, CAPA, Change Control, etc.