Job description
- Responsible for any packaging related activities in development lab or GMP area.
- Preparation of Master Packaging Card (MPC), batch packaging record (BPR) along with other GMP Non GMP packaging documents (protocols, reports etc).
- Development of New change parts for blister packing.
- Review of executed and master batch packaging records.
- Taking care of GMP documentation including change control, SOP, deviation, market complain etc.
- Innovator pack analysis and report preparation.
- Preparations of departmental SOP.
- Initiation of Change control, Deviation and CAPA in Track Wise for Packaging related activities.
- Coordination with supplier for development of new / existing Packaging Materials or change parts.
- Coordination with Analytical, Formulation Warehouse departments for analytical activities of Packaging Materials.
- Packing of Clinical / Developmental batches at pilot formulation development lab.
- Periodic review of packaging materials inventory and initiating PR for the packaging material order / procurement
- M. pharm / B. Pharm, candidate with IIP will be added advantage.
- Preparation / Review of Master Packaging card, Bill of Materials and Batch Packaging Record.
- Monitoring inventory for packaging material and purchase of new materials.
- Preparation / Review of Specification / STP / SOP of Packaging materials
- Effective communication with Client for Packaging related matter.
- Reference Product pack analysis and preparation of pack characterization report
- Initiation of change control, Deviation and CAPA in Track Wise for Packaging related activities.
- Coordination with supplier for development of new / existing Packaging materials or change parts or new packaging instrument / equipment.
- Coordination with Formulation development for Packaging related activities.
- Trouble shooting for Packaging related activities
- Calibration qualification of packaging related instrument / equipment.
- Follow gxp (GMP, GDP, GLP, etc.) For all the processes.
Skills Required
Procurement, Formulation Development