QA Job in Cipla as Team Member -B. Pharma/ M.Sc candidates can apply!
Company Introduction: The job posting is for a Team Member – QA at a leading pharmaceutical company focusing on quality and compliance.
Job Details
- Posting Date: May 28, 2025
- Country: India
- State: Karnataka
- Location: Bommasandra
- Req Id: 92559
Job Description 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 respond 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 expectations and acquire GMP approvals.VII. 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.
VIII. 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.
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 license, FDA stall approvals by ensuring cross-functional interaction.
Qualifications and Skills
- 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: Bommasandra
