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Deputy General Manager- CMO

3 months ago

mumbai, India SUN PHARMA Full time

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.