Cipla QA Job Opening For BPharma – Apply Online Now
Team Member – QA
Posting Date: 3 Jul 2024
Country: India
State: Sikkim
Location: Rangpo
Req Id: 85944
Division Quality
Department Quality
Employment Type Permanent
Job Purpose
Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines
Accountabilities
I. Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner
II. Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies
III. Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness
IV. Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement
V. Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly
VI. Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals
VII. Prepare final draft
VIII. Collect, compile and review raw data and finalise 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
IX. Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP
X. 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
XI. Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction
Education Qualification B. Pharma/ M.Sc
Relevant Work Experience 3-4 years of experience in quality assurance department
Competencies/Skills
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Job Location Rangpo
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