Cipla QA Job Opening For BPharm – Apply Online
Junior Team Member – QA
Posting Date: 6 Jan 2025
Country: India
State: Sikkim
Location: Rangpo
Req Id: 91011
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 to respond to 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 smooth execution of new products.
- Coordinate with auditors and site teams for regulatory and customer inspection/audit at site to meet regulatory expectations and acquire GMP approvals.
- 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.
- Collect, compile, and review raw data and finalize the same for timely submission of MHRA, UK interim update document to corporate as per agency requirements, 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 ensure GMP compliance and obtain 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
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
Keywords: Cipla, Junior Team Member QA, Job Posting, India, Sikkim, Rangpo, Quality, Pharmaceutical, Healthcare. Cipla QA Job Opening For BPharm – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
