Junior Team Member – QA at Cipla
About Company
Review the compliance level of the site for deficiency response, and prepare master validation protocols and reports as per the company quality policy and applicable regulatory guidelines.
Position Details
| Position Name | Organization | Qualification | Experience | Salary | Location |
|---|---|---|---|---|---|
| Junior Team Member – QA | Cipla | B. Pharma or M.Sc | 2 Years | ₹25,000 – ₹35,000/month | Ranpo, Sikkim |
Accountabilities
- Regulatory Responses: Collate, review, and provide work plans for deficiencies to the Head Office for timely regulatory responses.
- Validation Protocols: Review master validation protocols and reports to ensure timely execution of validation batches.
- Annual Product Quality Review: Ensure completeness and correctness of annual product quality review reports for compliance with cGMP and audit readiness.
- Technical Agreements: Manage and issue regulated market technical agreements to execute batches per customer requirements.
- Approval Distribution: Distribute approval certificates, dossiers, and development reports for smooth execution of new products.
- Audit Coordination: Coordinate with auditors and site teams for regulatory and customer inspections to meet regulatory expectations and acquire GMP approvals.
- Audit Observations: Prepare compliance drafts for audit observations, ensuring alignment with cGMP requirements.
- Data Compilation: Compile and review raw data for timely submission of MHRA, UK interim update documents, and track interim updates.
- Continuous Improvement: Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP.
- Submission Accuracy: Ensure accurate and timely submissions of product licenses, certificates, and staff approvals.
- Inspection Support: Support CDSCO and state FDA inspections to be GMP compliant and obtain product licenses and approvals.
