Cipla BPharma QA Job – Apply Online Now
Junior Team Member – QA (80641)
Requisition ID 80641 – Posted 05/12/2023 – India – Sikkim – Rangpo
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
- 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 response for deficiencies
- Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness
- Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement
- Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly
- Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals
- Prepare 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 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
- 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 licence, FDA stall approvals by ensuring cross functional interaction
Education Qualification
B. Pharma/ M.Sc
Relevant Work Experience
2 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
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