Date PostedFebruary 7, 2023
Location (State / UT)
Experience6 Years, 9 Years
Desired QualificationBachelor Degree
Roles and Responsibilities:
- To provide support to the group to ensure the achievement of CMC Quality accountabilities and responsibilities of Baroda R&D.
- To be accountable for developing procedures/systems and for assuring compliance to them by the R&D function.
- To ensure the 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 & adequacy, and justification prior to transfer to manufacturing sites
- To 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.
- To implement and monitor enabling processes/practices, such as the R&D stage gate process, development standards, and acceptance criteria.
- To ensure the Compliant Development of Analytical Methods, Method Qualification, and Method Validation activities related to Chemical Entities, API, and their method transfers to the manufacturer organization.
- Review of Harmonization Sops, Guidelines, and implementation
- Review of 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
- Reviewing deviation/Change controls / CAPA and associated investigation reports prior to Technology Transfer
- Knowledge on evaluation of Nitrosamine impurities in drug substances, raw materials, intermediates
Desired Candidate Profile:
- Educational Qualification – M.Sc (Organic Chemistry)