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12/09 Vinod Gopishetty
Senior Manager - Talent Acquisition at Jubilant Life Sciences Ltd

Views:210 Applications:36 Rec. Actions:Recruiter Actions:0

Jubilant Lifesciences - DGM - Quality Assurance - Formulation Plant (15-24 yrs)

Roorke/Uttarakhand Job Code: 4725

DGM - Quality Assurance ( Formulation Plant ) - Roorkee, Uttarakhand

Job Description :

- Review changes in Pharmacoepia, regulatory guidelines and observations in regulatory inspections faced by other industries and ensure the compliance at site for the same.

- Coordinate with corporate Quality Assurance to Develop and implement the Quality Systems of the Company for various sites .

- Plan and provide support to manufacturing activities in compliance to Quality Management Systems (QMS) / GMP guidelines.

- Review Technical investigations, Risk Assessments and its management by ensuring appropriate CAPA.

- Review and approve change controls for all API formulation plants of the site and analyze impact.

- Design and implement validation master plan, site master files, validation and Qualification template protocols.

- Monitor adherence to cGMP / Pharmacopoeia requirements;

- Identify training needs of quality teams; Conduct GMP, training programs for employees.

- To coordinate with US and European customers for obtaining their approvals on the changes made, for providing the compliance to their queries / audits.

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