Junior Team Member – QA | Cipla Ltd | Goa

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Job Overview

  • Date Posted
    27/01/2023
  • Location (State / UT)
  • Expiration date
    --
  • Experience
    2 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree, Master’s Degree
  • Salary in (₹)
    Negotiable

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

Accountabilities

  • 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