Deputy General Manager- Cmo

3 weeks ago


Mumbai, Maharashtra, India Sun Pharmaceutical Industries Full time

b Title Deputy General Manager- CMO Date Jun 21 2024 Location Sun House - Corporate Office Company Sun Pharmaceutical Industries Ltd Sun Pharma Corporate Quality Audit DepartmentPosition Deputy General ManagerLocation MumbaiReporting Manager Title VP Head Corporate Quality Compliance Department Corporate QualityJob Summary Responsible for overall quality oversight functions of contract manufacturing organizations responsible for manufacturing of site transfer products Sun site R D for US market Essential Job Functions Caused based frequent visits of the CMO sites for review of process practices Coordinate with Sun site commercial corporate quality audit the CMO site as SPOC for activities related to product manufacturing and release and other technical issues To review approve quality agreements between Sun Pharma CMO site Also ensure qualified and approved external service providers are used To participate in new product launch evaluation and technology transfer To monitor ensure timely closure of market complaints quality alerts recalls etc Review and approval of process validation analytical validation hold time study stability study protocols reports Tracking of open CAPAs and ensure effectiveness of CAPAs Review approval of annual risk assessments To monitor evaluate product remediation Tracking implementation of new projects as CMO sites Review and approve SOPs as per Sun Pharma quality standards Ensure timely implementation of Pharmacopoieal changes compliance To ensure timely release of batches in SAP system Requirements and Qualifications Basic Qualification M Sc B Pharm M Pharm or equivalent Industrial Experience Knowledge Total 22-25 years of experience in Production Quality Assurance Quality and compliance in sterile formulations manufacturing Knowledge of GMPs in both domestic and international regulatory environments In-depthknowledge of FDA guidances such as ICH is must Strong organizational interpersonal and communication skills Ability to work effectively in multicultural matrix organization



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