Latest Pharma Jobs at Cipla | MSc Graduates Apply Now for the Junior Team Member – QA Role
Looking for a career in quality assurance within the pharmaceutical industry? This Junior Team Member – QA role in Rangpo, Sikkim offers the opportunity to work on compliance reviews, regulatory documentation, and audit preparedness while ensuring adherence to cGMP and quality standards. Ideal for candidates with QA experience seeking growth in a dynamic and regulated environment.
- Job Title: Junior Team Member – Quality Assurance
- Location: Rangpo, Sikkim, India
- Req ID: 95155
About The Company
Cipla Limited is a leading global pharmaceutical company headquartered in Mumbai, India, renowned for its commitment to providing affordable and high-quality medicines across more than 80 countries. Established in 1935, Cipla has a diverse product portfolio spanning respiratory, oncology, cardiology, anti-retroviral, and other therapeutic areas. The company is widely recognized for its pioneering role in making HIV/AIDS medications accessible at low cost and continues to focus on innovation, sustainability, and patient-centric healthcare solutions. With state-of-the-art manufacturing facilities, robust R&D capabilities, and a strong global presence, Cipla plays a crucial role in improving healthcare outcomes worldwide.
Key Responsibilities:
Deficiency Response & Compliance:
- Collate, review, and provide work plans on received deficiencies to HO for timely regulatory submissions.
- Collect and review data from all SPOCs, escalate delays, and synchronize validation documents across units.
- Follow up with HO for updated dossiers and product updates.
Validation & Document Review:
- Review master validation protocols and reports within timelines.
- Check observations from other units to improve site documentation.
- Review annual product quality reports (APQR) for completeness and data accuracy.
Audit & Inspection Coordination:
- Coordinate with auditors and site teams for regulatory and customer inspections.
- Prepare compliance drafts aligned with cGMP to meet regulatory expectations.
- Inspect prerequisites and support external audits.
Regulatory Applications & Licensing:
- Review and submit applications for product licenses, COPP, test licenses, renewals, WHO GMP certificates, FDA staff approvals, and alcohol quotas.
- Ensure timely communication with FDA and track approval statuses.
Continuous Improvement & Training:
- Drive cGMP improvements by reviewing competitor warning letters and audit observations.
- Conduct self-inspections, develop CAPA plans, and provide departmental training for compliance awareness.
Regulatory Data Management:
- Collect and review raw data for MHRA updates, prepare interim reports, and track inspection planning.
- Maintain zero overdue compliance and 100% adherence to timelines for document review.
Major Challenges:
- Delays in receiving work plan data impacting deficiency responses.
- Handling observations in validation documents affecting batch registrations.
- Liaising with government officials for timely approvals.
- Ensuring root cause analysis and detailed compliance responses.
Key Interactions:
- SPOCs for validation, APQR, and RA for timely data (weekly/monthly).
- Unit QA heads, CQA, and A&C teams for compliance and audits.
- FDA officials for processing applications and approvals.
Work Dimensions:
- Zero overdue deficiencies; 100% document review adherence.
- Average 30 audits per year; quality score minimum 90% monthly.
- FDA interactions: ~150 additional product licenses, 36 test licenses, 40 certificates, 290 COPP, 5 staff approvals.
Key Decisions:
- Recommend and review observations for master validation protocols, APQRs, and deficiency responses.
- Identify root causes for inspection observations and regulatory compliance issues.
Qualifications:
- Education: B.Pharm or M.Sc. with minimum 3–4 years of QA experience.
- Licensing & Registration: 0–2 years preferred.
- Skills: Sound knowledge of cGMP and regulatory guidelines; basic computer skills.
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