Dgm Corporate Quality

4 days ago

Mumbai Maharashtra, India Sun Pharmaceutical Industries Ltd Full time

**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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