Deputy General Manager- CMO
3 days ago
Sun Pharma Corporate Quality Audit Department
Position: Deputy General Manager
Location: Mumbai
Reporting Manager Title: VP & Head Corporate Quality & Compliance
Department: Corporate Quality
Job 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 CAPA’s and ensure effectiveness of CAPA’s.
• Review & approval of annual risk assessments.
• To monitor & evaluate product remediation.
• Tracking & implementation of new projects as CMO sites.
• Review and approve SOP’s 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 GMP’s in both domestic and international regulatory environments. In-depth
knowledge of FDA guidance’s such as ICH is must.
• Strong organizational, interpersonal and communication skills.
• Ability to work effectively in multicultural matrix organization.
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