- Full Time
- Tandalja (Vadodara)- R&D
Website Sun Pharma
About Sun Pharma
Sun Pharma is indeed one of the leading pharmaceutical companies globally, holding the position of the fourth largest generic pharmaceutical company in the world. Within India, it stands as the largest and most valuable pharmaceutical enterprise based on its size and market capitalization. The company is renowned for its commitment to delivering high-quality medicines that are trusted by customers and patients in more than 150 countries. Sun Pharma boasts multiple manufacturing facilities and research and development (R&D) centers, underlining its dedication to innovation and excellence.
A notable aspect of Sun Pharma’s leadership philosophy is their approachability. The company’s leaders are known for recognizing and supporting the aspirations of their employees for personal and professional growth. They value input from their team members and empower them to make positive changes within the organization. This emphasis on inclusivity and collaboration helps drive innovation and growth within the company, ultimately contributing to its success in the pharmaceutical industry.
Job Post: Research Scientist
- New Submissions: a. CMC Dossier Preparation: Review and prepare Chemistry, Manufacturing, and Controls (CMC) dossiers for fresh submissions. b. Document Review: Examine development reports, scale-up reports, specifications, stability protocols, artworks, etc., for adequacy before initiating Exhibit batches.
- Approval Process: Review and prepare responses to deficiencies to enable approval of products filed with regulatory agencies.
- Lifecycle Management for Drug Formulations: a. Variations Preparation: Prepare and review variations in accordance with country-specific requirements to support changes such as API vendor changes, alterations in ROS/test parameters, DF site changes, harmonization of products, etc.
- Regulatory Compliance: a. Approval Package Preparation: Create, review, and distribute approval packages with product history sheets to stakeholders upon approval receipt, updating them as needed based on queries and variations. b. Central Repository Management: Ensure comprehensive product information is repositioned into the central repository.
Location: Tandalja (Vadodara) – R&D
To apply for this job please visit careers.sunpharma.com.