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
