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Title:  DGM Corporate Quality

Date:  Apr 11, 2025
Location:  Sun House - Corporate Office
Company:  Sun Pharmaceutical Industries Ltd

 

Position: Deputy General Manager

Department: Corporate Quality

Location: Mumbai

Reporting Manager Title: Quality Cluster 3 Head

Classification: CMO Quality
Sun Pharma Corporate Quality Audit Department

 

Job Summary:

  • 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.

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