20000+ employees. 80 countries. Our secret of success, if you will, is something so simple, so pure, and yet so powerful. It’s our Purpose- “Caring for Life”. It inspires us to find innovative solutions to patients’ unmet needs and forms the core of how we do business. It propels us to create value to the communities that we serve and we’ve been recognized aplenty for this.

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But what makes us truly smile? When our employees reach for the stars. And we do our bit to take them there-encouraging them to take up opportunities across our global offices, creating a challenging work environment, and most importantly, standing by them, no matter what!  So, has our purpose begun to resonate with yours? Next step. Hit the button below!

Position: Junior Team Member – QA

Location: Goa, India

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 to 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 certificate, dossiers (TDP & RAP), and development report at the unit for execution of new products smoothly
  • Coordinate with auditors and site teams for regulatory and customer inspection/ audit at the site to meet the regulatory expectation and acquire GMP approvals
  • Prepare the final draft of compliance to audit observation and check whether it is in line with cGMP requirement 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 license, 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

Qualification: B. Pharma/ M.Sc

Experience: 2 years of experience in the quality assurance department

Salary: Negotiable

Contact Details:

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