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About Company

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.

Position Name :

Junior Team Member - QA

Organization :

Cipla

Qualification:

B. Pharma/M.Sc

Experience:

2 years of experience

Salary:

25,000 - 35,000 /month

Location:

Goa

Accountabilities:

  • Deficiency Response: Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner.
  • Validation Protocol: Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to respond for deficiencies.
  • Product Quality Review: Review annual product quality review report at units for completeness and data correctness to ensure compliance with cGMP requirements and audit readiness.
  • Technical Agreements: Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirements.
  • Approval Distribution: Receive and distribute approval certificates, dossiers (TDP & RAP) and development reports at unit for smooth execution of new products.
  • Audit Coordination: Coordinate with auditors and site teams for regulatory and customer inspection/audit at site to meet regulatory expectations and acquire GMP approvals.
  • Audit Compliance: Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirements to avoid regulatory action and ensure continual improvements.
  • Data Compilation: Collect, compile and review raw data and finalize the same for timely submission of MHRA, UK interim update documents to corporate as per agency requirements by tracking interim updates at a site level for risk-based inspection planning.
  • Continuous Improvement: Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP.
  • Errorless Submissions: 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.
  • Regulatory Support: Support in CDSCO and state FDA inspection to be GMP compliant and get product licenses, FDA stall approvals by ensuring cross-functional interaction.

Application Link