Job Summary
Responsible for ensuring quality compliance of Finished Dosage Formulations (FDF) sourced from third-party manufacturers for international markets. The role involves vendor qualification, batch document review, product release coordination, quality documentation management, and ensuring compliance with applicable GMP and export market requirements.
Key Responsibilities
Quality Assurance & Compliance
- Ensure products supplied by contract manufacturers comply with approved specifications and regulatory requirements.
- Review and approve batch manufacturing records, batch packing records, Certificates of Analysis (CoA), and related quality documents.
- Monitor compliance with GMP, WHO-GMP, and applicable international quality standards.
- Support implementation and maintenance of Quality Management Systems (QMS).
Vendor Qualification & Management
- Conduct vendor qualification and periodic performance reviews of contract manufacturing partners.
- Coordinate vendor audits and ensure timely closure of audit observations.
- Review GMP certificates, quality agreements, and technical documents from manufacturers.
- Monitor supplier quality performance and compliance status.
Product Release & Documentation
- Verify batch documentation and facilitate batch release for export shipments.
- Review product specifications, stability data, validation documents, and quality-related records.
- Maintain quality documentation, SOPs, change controls, deviations, CAPAs, and investigation records.
- Ensure proper archival and retrieval of quality documents.
Regulatory & Cross-Functional Coordination
- Support Regulatory Affairs with quality documentation required for product registrations and renewals.
- Coordinate with Sourcing, Supply Chain, Regulatory, and Manufacturing partners on quality-related matters.
- Assist in handling customer complaints, product quality issues, and market feedback.
Quality Systems & Continuous Improvement
- Participate in internal audits, vendor audits, and quality reviews.
- Track and monitor deviations, OOS/OOT results, CAPAs, and change controls.
- Support quality improvement initiatives and compliance enhancement programs.
Qualifications & Experience
- B.Pharm / M.Pharm / B.Sc. / M.Sc. in Life Sciences, Chemistry, or related field.
- 2–5 years of experience in Quality Assurance within the pharmaceutical industry.
- Experience with Finished Dosage Formulations (FDF) and third-party manufacturing operations preferred.
Required Skills
- Strong understanding of GMP, WHO-GMP, GDP, and pharmaceutical quality systems.
- Knowledge of batch release processes and quality documentation.
- Familiarity with vendor qualification, audits, deviations, CAPA, and change control systems.
- Strong analytical, documentation, and problem-solving skills.
- Proficiency in Microsoft Office applications.
- Effective communication and stakeholder management skills.
Key Performance Indicators (KPIs)
- Timely review and release of export batches.
- Vendor compliance and audit performance.
- Closure of deviations, CAPAs, and quality investigations within timelines.
- Reduction in quality-related complaints and non-conformances.
- Compliance with GMP and quality system requirements.
- Accuracy and completeness of quality documentation.
Employment Type: Full-Time | Based in: Kochi | Send your resume to [email protected]
Job Types: Full-time, Permanent, Fresher
Pay: ₹25,000.00 - ₹35,000.00 per month
Benefits:
- Health insurance
- Paid time off
- Provident Fund
Experience:
- Pharmaceutical : 1 year (Required)
Location:
- Kochi, Kerala (Preferred)
Work Location: In person
