Junior Team Member – QA | Cipla Ltd | Goa

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Job Overview

  • Date Posted
  • Location (State / UT)
  • Expiration date
  • Experience
    2 Years
  • Gender
  • Desired Qualification
    Bachelor Degree, Master’s Degree
  • Salary in (₹)

Job Description

Job Purpose

Review the compliance level of the site for deficiency response, prepare master validation protocol, and report as per company quality policy and applicable regulatory guidelines


  • Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner
  • Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to respond for deficiencies
  • Review annual product quality review report at units for completeness and data correctness to ensure compliance with cGMP requirements and audit readiness
  • Review, upkeep, and issue regulated market technical agreements at the site for execution of batches as per customer requirement
  • Receive and distribute approval certificates, dossiers (TDP & RAP), and development reports at the unit for the execution of new products smoothly
  • Coordinate with auditors and site teams for regulatory and customer inspection/ audit at the site to meet the regulatory expectations and acquire GMP approvals
  • Prepare the final draft of compliance to audit observation and check whether it is in line with cGMP requirements to avoid regulatory action and continual improvements
  • Collect, compile and review raw data and finalize the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk-based inspection planning
  • Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP
  • Execute on-time and errorless submissions by reviewing product licenses, all certificates for product registration and tender, staff approvals, and other applications to adhere to legal requirements
  • Support in CDSCO and state FDA inspection to be GMP compliant and getting product license, FDA stall approvals by ensuring cross-functional interaction
Education Qualification

B. Pharma/ M.Sc

Relevant Work Experience

2 years of experience in the quality assurance department