Sun Pharmaceutical Industries Ltd. is one of the largest pharmaceutical companies in India and a leading global specialty generic player. With a strong presence in over 100 countries, Sun Pharma is known for its high-quality, affordable medicines and cutting-edge R&D.
Job Description (JD)
Key Responsibilities:
- Process Execution & Monitoring:
- Execution and monitoring of trial, scale-up, and exhibit process qualification batches.
- Ensuring compliance with regulatory and cGMP guidelines.
- Documentation & Review:
- Preparation and review of new product documents, including:
- Material Requirement Sheet (MRS)
- Master Formula Card (MFC)
- Bill of Material (BOM)
- Risk Assessment Reports
- Sampling Protocol & Reports
- Exhibit Batch Manufacturing Records
- Exhibit Protocols & Reports
- Preparation and review of new product documents, including:
- Regulatory & Compliance Support:
- Preparation of investigation reports (OOS/OOT) for exhibit/validation/commercial batches.
- Handling deviations, justifications, and additional activity protocols.
- Supporting regulatory submissions and evaluations.
- Stability Testing & Failure Analysis:
- Investigating and documenting failures during stability testing.
- Providing technical justifications and corrective actions.
Desired Skills & Competencies:
- Strong knowledge of oral solid dosage (OSD) manufacturing processes.
- Experience in process validation, scale-up, and technology transfer.
- Familiarity with cGMP, ICH guidelines, and regulatory requirements (USFDA, EU GMP, etc.).
- Proficiency in documentation, deviation management, and CAPA.
- Excellent analytical and problem-solving skills.
How to Apply?
Interested candidates meeting the eligibility criteria can send their updated resume to:
📧 Email: Rosemary.varghese@sunpharma.com
