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Description: Job Description - Visiting to DS manufacturing and warehouse facility to ensure that activities are being carried out by following GMP requirements, Regulatory requirement and as per approved procedures. - To participate in the manufacturing investigation and CAPA finalization activity. - Preparation and review the Risk Assessment and Mitigation Plan. - Ensure that process and cleaning validation activities are being carried out by following approved protocols. - Review of master document like study protocol, BPR, MFR etc. - Review of executed Batch Processing Records for Batch Release. - Review of Batch Dispatch Record and verification of dispatch activities in warehouse. - Overall coordination for the APQR data compilation and APQR preparation activity. - Preparation and review of Quality System SOPs & documents. - Review of SOPs as per GMP requirements for all departments. Work Experience 6 to 9 Years Education Masters in Biotechnology or Biotechnology Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation