Section Head – QMS & Compliance | Cipla Ltd | Bangalore

Manufacturing, QA/QC/QMS/IPQA/CQA
Karnataka
February 12, 2023
Full Time
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Job Overview

  • Date Posted
    February 12, 2023
  • Location (State / UT)
    Karnataka
  • Expiration date
    --
  • Experience
    8 Years, 12 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

Job Purpose

Plan, coordinate for audits, and track the compliance of contract manufacturing units / PTL, monitor the implementation of QMS, review all master documents and APQR data, and perform timely release of batches manufactured as per process in order to ensure the capability of contract manufacturing units to manufacture and deliver quality products and meet regulatory compliance.

Accountabilities

  • Plan and conducts the audits of existing / new proposed CMOs/PTLs, review audit non-compliance, and recommend CAPAs to ensure the manufacturing unit can produce quality products
  • Plan and execute the risk management program for contract manufacturing units to identify, prioritize and mitigate quality risks for patient safety and product quality
  • Review and approve the deviations, change request, and CAPA in order to ensure quality product release in the market and no recurrence of the deviation with compliance cGMP
  • Review and approve the market complaint to ensure that adequate investigation is done to find out the root cause and CAPA to avoid the reoccurrence of similar nature of the market complaint and no impact on patient safety and regulatory compliance.
  • Review the batch failure and recall of batches due to process error, stability issues, complaints, etc. by ascertaining all the aspects of investigation thereby ensuring that no product deficient is released in the market and no defective product is available in the market leading to regulatory action and patient health impact
  • Review batch release documents of contract manufacturing units to ensure the quality of product release in the market within time to meet the regulatory requirements
  • Review and assess master batch documents to ensure all the required instructions are maintained to manufacture quality products while meeting customer and regulatory requirements
Education Qualification

B. Pharma, B.Sc/ M.Sc

Relevant Work Experience

8-12 years of experience in quality assurance of a pharmaceutical organization

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