- Compliance with GMP norms and to be following cGMP in manufacturing area.
- To prepare and approval of material requisition order to store and follow-up till receipt of raw materials.
- Verification of raw material/packing material during dispensing as per BMR and receipt of raw materials and packing material as per BMR from warehouse.
- Manufacturing, packing and Documentations as per BMR and SOP.
- To verify quality system in the production department.
- Preparation and review of standard operating procedures relevant to production department and to review of List of equipment and equipment re-qualification planner.
- Wearing appropriate PPE and following safety procedures for personnel/product safety as per Safety SOP.
- Preparation and review of master formula record, process records, reprocess record, repacking record, regular BMRs and ECR.
- Responsible for initiation of QMS documents like change controls, deviations, OOS, OOT, CAPA and conduct failure mode investigations.
- Preparation of URS, PQ documents and review of DQ, IQ, OQ and other qualification documents.
- Responsible to comply the requirements of technical audits and safety audits.
- Preventive maintenance and calibration planning according to schedule.
- Responsible for complying with all production-related documents.
- Interaction with warehouse/quality assurance for material availability / release of raw material and packing materials intermediate and finished goods.
- Co-ordination with engineering for maintenance / machine breakdown / modification / calibration.
- Check on production yields and re-conciliation at various stages of manufacturing.
- Responsible for maintaining production blocks tidy.
- Responsible for production planning and achieving maximum production by utilizing all resources to deliver the API on target timelines to fulfill customer needs.
- Maintaining harmonious relations with employees.
- Updating of equipment status board, usage logbook & relevant records as per BMR/ECR/SOP.
- Proper segregation of material, labelling and identification, area cleaning and disinfection.
- Raising test requisition to QA / QC and follow-up till release of test report.
- Ensure cleanliness of hard to clean parts of equipments during cleaning for product-changeover (campaign cleaning) and to ensure regular cleaning between batch to batch of the same product.
- To assure batch uniformity and integrity of drug products through written procedures followed by in process controls and tests of each batch.
- Submission of completed BMR, other completed records and raising BMR/ECR requisition to QA as per production planning.
- Maintaining equipments and area cleanliness as per requirement.
- To monitor outputs and to validate the performance of manufacturing process.
- Responsible for exploring ideas and implementing latest technologies in the production and keeping on update with the regulatory requirements and latest guidelines.
- Attending training as per annual training calendar.