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Designation: Manager CMC QA
Location: Vadodara, Gujarat, Maharashtra
Job Description:
- To provide support to the group to ensure 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 justified prior to transfer to manufacturing sites
- To assure that process development packages up to filling Stage of R & D deliverable is 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 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
Qualification: M.Sc, B.Pharma/M.Pharma
Experience: 8-13 Years
Salary: Negotiable
Contact Details:
vignesh.iyer@sunpharma.com
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