Roles and Responsibilities
Quality management system
- Coordinate with the cross-functional department for execution of training planners and maintain training records for same.
- To master, issue, and retrieve SOPs/BMR/BPR/QC dockets and other documents in line with the laid down procedure.
- To maintain vendor-related documents and conduct vendor audits.
- To investigate and prepare a Market Complaint investigation report.
- To take follow up and communicate with customers/vendors regarding Complaints.
- To handle Change control/Deviations/Incidents/NCR/CAPA.
- Review of quality technical agreements.
- To prepare process validation and Bulk hold Time Study protocol and report.
- Execution and compilation of Process Validation and Bulk hold time study as per protocol.
- Preparation of Annual Product Quality Review
Desired Candidate Profile
Candidate must have experience in Injectable plant
Qualification: B.Pharma, M.Pharma, MS/M.Sc