Chemistry Executive Role at Sun Pharma – Apply Now!
Title: Sr. Executive – CMC QA (API)
Date: Sep 12, 2024
Location: Tandalja – R&D
Company: Sun Pharmaceutical Industries Ltd
Job Title: Sr. Executive – CMC QA
Job Grade: G11
Department: R&D Quality, CMC QA
Location: Baroda
Manager’s Job Title: Sr. Manager -1
Department Head Title: Quality R&D Head
Job Summary
This position in the R&D Quality, CMC QA team is responsible for reviewing and monitoring the R&D quality systems in the development areas of API Research & Development at Sun Pharma, Vadodara.
Area of Responsibility
- Provide support to the group to ensure the achievement of CMC Quality accountabilities and responsibilities of Gurgaon R&D.
- Develop procedures/systems and ensure compliance by the R&D function.
- Ensure compliant development of chemical entities, key starting materials, intermediates, API, and their technology transfers to the manufacturing organization.
- Review and audit R&D procedures, specifications, stability data, reports, and SLP/process packages and other technology transfer documents of drug substance/intermediates development for completeness and adequacy prior to transfer to manufacturing sites.
- Assure that process development packages up to the filling stage of R&D deliverables are reviewed adequately within the team to verify scientific rigor, adequacy, and completeness.
- Implement and monitor enabling processes/practices, such as R&D stage gate process, development standards, and acceptance criteria.
- Ensure compliant development of analytical method, method qualification, and method validation activities related to chemical entities, API, and their method transfers to the manufacturer organization.
- Review harmonization SOPs, guidelines, and their implementation.
- Review facility and equipment qualification and calibration records.
- Support and participate in failure investigations and resolution of root causes for issues related to systems and products developed within Sun Pharmaceutical Industries Limited.
- Review deviations/change controls/CAPA and associated investigation reports prior to technology transfer.
- Knowledgeable on the evaluation of nitrosamine impurities in drug substances, raw materials, intermediates.
Education and Job Qualification
- A minimum of a Master’s degree in Science/Pharmaceutical science, M.Sc (Organic Chemistry), or M.Pharm (Chemistry) or a related discipline.
- Experience in the pharmaceutical industry, with an emphasis on quality assurance or in a research environment, is desirable.
Technical Competencies
- Literature search methodologies
- Sound knowledge of process chemistry
- Ability to analyze chemistry problems
- Ability to proactively understand scale issues and resolve them
- Knowledge of materials (raw materials, solvents, etc.) and products (intermediates, API)
- Understanding of major IP and regulatory guidelines globally
- Knowledge of GxP (GLP, GMP, etc.)
- Knowledge of EHS to develop safe processes
- Knowledge of QbD
Experience
- Minimum of ten (10) years of experience within the pharmaceutical industry in Development Quality Assurance/Quality Assurance (API manufacturing).
Link to apply: Apply Here
Keywords: Sr. Executive CMC QA, API, Quality Assurance, Pharmaceutical Industry, Research & Development, Sun Pharma. Chemistry Executive Role at Sun Pharma – Apply Now! Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
