DGM Corporate Quality

Job description

• Responsible for overall quality oversight functions of contract manufacturing organizations responsible for manufacturing of site transfer products (Sun site & R&D) for Domestic 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.