Cipla is a leading global pharmaceutical company committed to delivering high-quality, affordable medicines to patients worldwide. With a strong presence in over 80 countries, Cipla focuses on innovation, compliance, and excellence in healthcare. The company fosters a collaborative work environment where employees can grow professionally while contributing to meaningful healthcare solutions.
Job Description
Job Purpose:
As a Junior Team Member – QA, you will be responsible for reviewing site compliance for deficiency responses, preparing master validation protocols, and ensuring adherence to company quality policies and regulatory guidelines.
Key Responsibilities:
- Deficiency Response Management
- Collate, review, and provide work plans for regulatory deficiencies.
- Escalate delays in receiving responses and ensure timely submission to HO.
- Master Validation Protocol & Report Review
- Ensure timely review of validation documents.
- Identify major observations and synchronize improvements across units.
- Annual Product Quality Review (APQR)
- Review APQR reports for completeness and compliance with cGMP.
- Technical Agreements (TA) Review
- Ensure execution of batches as per customer requirements.
- Provide training on compliance and audit readiness.
- Regulatory & Customer Audit Coordination
- Prepare compliance drafts for audit observations.
- Monitor CAPA implementation for continual improvement.
- FDA & Licensing Compliance
- Process applications for product licenses, COPP, and FDA approvals.
- Track alcohol quota and staff approvals as per regulatory requirements.
Major Challenges:
- Delays in data collection for deficiency responses.
- Handling major observations in validation documents.
- Ensuring timely approvals from regulatory authorities.
Key Interactions:
- Internal: QA Heads, CQA, Regulatory Affairs (RA) teams.
- External: FDA officials, regulatory auditors.
Qualifications & Experience:
- Education: B.Pharma / M.Sc
- Experience: 0-2 years in licensing & registration.
- Skills: Strong knowledge of cGMP, regulatory guidelines, and computer systems.
