The incumbent will be responsible to develop Sterile manufacturing processes that result in continuous improvement and lowering of unit costs. Establishes internal / external benchmarking and measurements for the maintaining high level of GMP & other regulatory standards throughout the sterile production facility.
- Lead a team in order to work on process innovation, continuous improvement and sustainability in routine processes as per cGMP standards.
- Ensure compliance of all procedures, processes and system as per WHO and other international standards.
- Review and approve the Batch manufacturing records and manufacturing orders for commercial and stability batches of sterile products.
- Authorize to supervise the material transportation, dispensing, compounding, filtration, autoclaving, filling, capping & optical inspection operations in sterile manufacturing area.
- Make all entries in SAP after completions of manufacturing steps.
- Monitor the compliance of all documents and ensure the timely revision/preparation of SOPs.
- Manage and facilitate the validation and calibration activities in sterile production area.
- Training and development of Sterile Production team on different equipment and procedures.
- Manage and facilitate media fill trials (biannually) in Sterile production area.
- Work in coordination with Supply chain and QC to ensure the timely availability and release of raw material, packaging materials and finished products as per requirements.
- Coordinate with Regulatory department for the preparation and timely submission of sterile products dossiers to ministry of health.
- Ensure the plan conformance and fulfill marketing demand.
- Ensure good documentation practices are followed & log books and BMRs are timely updated.
Required Knowledge & Experience
- Minimum Pharm D from reputable a reputable institute.
- Should have at least 05 to 12 years’ recent experience in sterile manufacturing.
- Must have experience of aseptic & terminal sterlization techniques.
- Advanced knowledge of pharmaceutical guidelines, sterlization, process simulation & good manufactuing practices.
- Basic knowledge of cold chain products manufacturing & storage.