Site Head (DGM) Quality Assurance (Topical)  - Inviting applications for Quality Assurance professional with 15+ years of hands on experience in Topical Plant. The Candidate should possess good knowledge of topical suspensions, Cream, Ointment (Most Preferred).   Below the brief job description for the role :   - Responsible for overall quality functions and compliance of cGMP at the site.  - To assist corporate QA for evaluation and qualification of vendors for raw materials and packaging materials and service providers if applicable.  - To ensure and support the investigations of the Market complaints, Deviations and Incidences to find out the root cause and review corrective and preventive action plan.  - To coordinate with Regulatory Agency and QP (if applicable).  - To coordinate with Corporate QA, QC, RA and PTC on Technology transfer requirements.  - To ensure compliance with the commitment given in the Validation and Qualification policy of the company at the sites from the initial stage.  - To conduct self-inspection at site as per planner and prepare the site for external audits.  - To prepare the compliance report for the external audit.  - To track deviation, incidences, complaints, non-conformance (if any) at site, ensure closure of the same as per the timeline given in the respective SOPs and recommend action plan for preventing re occurrence of similar nature of events.  - To coordinate with Production, HR, Engineering, QC, Warehouse for compliance as per cGMP and Regulatory Requirements.  - Approval signatory for all SOPs Master Batch Records, Qualification Validation documents of Analytical and Manufacturing equipment, Specifications, Change Control, OOS investigations and other investigations, Stability Protocols, and other Master Documents.  - To prepare reports /Quality Metrics for quality indicating parameters and compliance status of the site Share the information with Corporate QA for periodic review and to appraise the Management.  - To ensure review of batch documentation and release of the batches for distribution in SAP.  - To review OOS investigations reports. Suggest for experimental design if assignable cause is not determined. Final closure of OOS investigation report and decision on batch disposition.  - To approve and authorized signatory for Technical Agreements, applicable to site

Gujarat

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Zydus Cadila - Site Head/DGM - Quality Assurance - Topical Plant 

Zydus Cadila - Site Head/DGM - Quality Assurance - Topical Plant  ,Job Description for Zydus Cadila - Site Head/DGM - Quality Assurance - Topical Plant  in Zydus Cadila in  Gujarat Others for (14-25) years of experience. Apply Now!

Job Description for Zydus Cadila - Site Head/DGM - Quality Assurance - Topical Plant  in Zydus Cadila in  Gujarat Others for (14-25) years of experience. Apply Now!