Junior Team Member – QA
Cipla – Goa
About Cipla:
Review compliance levels, prepare validation protocols, and report as per quality policy and regulatory guidelines.
Position Name: Junior Team Member – QA
Organization: Cipla
Qualification: B. Pharma/M.Sc
Experience: 2 years
Salary: ₹25,000 – ₹35,000/month
Location: Goa
Accountabilities:
- Deficiency Response: Collate, review, and provide work plans on received deficiencies for timely regulatory responses.
- Validation Protocol: Review Master Validation protocol and report for timely execution and submission of validation batches.
- Product Quality Review: Ensure completeness and correctness of annual product quality review reports to meet cGMP requirements.
- Technical Agreements: Manage and issue technical agreements for batch execution as per customer requirements.
- Approval Distribution: Distribute approval certificates, dossiers (TDP & RAP), and development reports for new product execution.
- Audit Coordination: Coordinate with auditors and site teams for regulatory and customer inspections to meet GMP approval requirements.
- Audit Compliance: Prepare final drafts of audit compliance to meet cGMP requirements and avoid regulatory actions.
- Data Compilation: Compile and review raw data for timely submission of MHRA, UK interim update documents as per agency requirements.
- Continuous Improvement: Drive initiatives in CQA to ensure adherence to cGMP.
- Errorless Submissions: Ensure on-time, error-free submissions of product licenses, certificates, and other applications.
- Regulatory Support: Support CDSCO and state FDA inspections to obtain product licenses and FDA stall approvals through cross-functional interaction.