About this role
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