Manager - 1 Fresher's job

To provide the Support to group to ensure achievement of CMC Quality accountabilities and responsibilities of Gurgaon R&D.

To be accountable for developing procedures / system 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 justified prior to transfer to manufacturing sites

To assure that process development packages up to filling Stage of R & D deliverable are reviewed adequately within the team to verify scientific rigor, adequacy, and completeness.

To implement and monitor enabling processes / practices, such as R&D stage gate process, development standards and acceptance criteria.

To ensure the 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 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