Carry out literature search for upcoming products and accordingly plan for product development. Preparation of product feasibility report. Knowledge in the formulation development of Parenteral dosage forms. Development flow for Parenteral dosage form. Guidance to fellow colleagues regarding development flow. Hands on experience in Formulation Development including pre-formulation study and Scale-up. Initiation of Filter validation study with filter supplier. To prepare Product development report (PDR). Good hand at Compatibility studies for Finish product. Visualize developmental needs of the product (i.e. API, Excipients, Packing materials). Solve the problems and quires related to the development of the formulation and discuss with team members. Transferring of new developed product to the Manufacturing site. Understand/Familiarize with the problems faced during scale-up batches, trouble shooting. Compilation and interpretation of routine analytical data. Preparation of SOPS, MFR, Stability & Hold Time studies protocol, writing of Lab notebooks. Preparation of in-process finished product specification and packing material specifications consulting with ADL personnel. Have Sufficient Knowledge of regulatory guidelines (EU, ROW and US Markets). To provide technical support for commercial batch manufactured. To perform investigation of failures during exhibit batches/stability study. Supporting role for OSD development including literature, documentation, and trial batches at FRD.
Job Responsibilities 1. Knowledge of Blistering processes and equipment. 2. Adhere to Good Manufacturing Practices (GMP) and standard operating procedures (SOPs) to ensure quality and safety. 3. Operate and clean equipment, including Blister Machine, Blister Change Parts, and Leak Test Apparatus. 4. Set up equipment for production runs, including the adjustment of machine settings and process parameters. 5. Perform various duties related to the area of the manufacturing process (Packing, Over Printing, Labelling, etc.). 6. Report any quality issues to the Production Supervisor or Quality Assurance team. 7. Troubleshoot mechanical issues and perform minor repairs as needed. Coordinate with maintenance personnel for major repairs and maintenance activities. 8. Follow all safety protocols and procedures to maintain a safe working environment.
1. Carry out literature search for upcoming products and accordingly plan for product development. 2. Preparation of product feasibility report. 3. Knowledge in the formulation development of Parenteral dosage forms. 4. Development flow for Parenteral dosage form. 5. Guidance to fellow colleagues regarding development flow. 6. Hands on experience in Formulation Development including pre-formulation study and Scale-up. 7. Initiation of Filter validation study with filter supplier. 8. To prepare Product development report (PDR). 9. Good hand at Compatibility studies for Finish product. 10. Visualize developmental needs of the product (i.e. API, Excipients, Packing materials). 11. Solve the problems and quires related to the development of the formulation and discuss with team members. 12. Transferring of new developed product to the Manufacturing site. 13. Understand/Familiarize with the problems faced during scale-up batches, trouble shooting. 14. Compilation and interpretation of routine analytical data. 15. Preparation of SOPS, MFR, Stability & Hold Time studies protocol, writing of Lab notebooks. 16. Preparation of in-process finished product specification and packing material specifications consulting with ADL personnel. 17. Have Sufficient Knowledge of regulatory guidelines (EU, ROW and US Markets). 18. To provide technical support for commercial batch manufactured. 19. To perform investigation of failures during exhibit batches/stability study. 20. Supporting role for OSD development including literature, documentation, and trial batches at FRD.
Knowledge of granulation processes and equipment. Adhere to Good Manufacturing Practices (GMP) and standard operating procedures (SOPs) to ensure the quality and safety. Operate and clean granulation equipment's, Planetary Mixer, Sifter, Paste Kettle, Tray Dryer, Multi mill, Drum Mixer and Octagonal Blender. Set up equipment for production runs, including the adjustment of machine settings and loading of materials. Performed various duties related to the area of the manufacturing process (Packing, Over Printing, Labelling etc.) Report any quality issues to the Production Supervisor or Quality Assurance team. Troubleshoot mechanical issues and perform minor repairs as needed. Coordinate with maintenance personnel for major repairs and maintenance activities. Follow all safety protocols and procedures to maintain a safe working environment.
1) Monitoring of Quality assurance functions and overall plant GMP compliance. 2) Review and Approval of Batch manufacturing record and Bath packing records. 3) Review and Approval of standard operating procedures of all department. 4) Self-inspection of all departments and follow of compliance maintain records. 5) Monitoring training of personnel. 6) Monitoring revision and Approval of Master Documents like Validation Master Plan VMP, VMR, Site master file SMF, Method Validation protocol and report. 7) Implementation and Monitoring overall Pharmaceutical Quality System (PQS), Quality Management System, Change Control, Deviation, CAPA, Product Complain. 8) To aware the management with areas of improvements. 9) Monitoring and ensuring overall plant systems, processes and producer are in the state of compliance with respect Qualification, Validation and calibration. 10.Hosting the vendor and Regulatory audits. 11.Approval and release of each batch being manufactured in accordance with the GMP compliance for distribution. 12.To establish, implement & oversite the Basic Development Quality Assurance system in R&D Department.