:

To assure Quality and cGMP compliance of the products being manufactured and Packed for Cephalosporin Block.

- To review MMD-I / BPR and release of the batches for further processing stage like Granulation, compression, coating, inspection, filling and packing.
- To ensure IPQA functions and periodical verification of in- process parameter as per batch record and SOP.
- To review & impact assessment of break down intimation slip (BDIS) and to advise precautions to be taken before, during and after attending BDIS & Closure of BDIS.
- Ensure timely review of executed batch processing record and stage clearance for further activity.
- Review and approval of Master MMD-I & Batch packing record • To deliver the training for IPQA/Shop floor Team as per schedule and as when required.
- To participate in Regulatory/Internal Audit and cGMP review meeting and facilitate its compliance.
- Preparation, review and approval of SOP and ensure proper implementation at shop floor.
- Intermediate & final Release of Finished Product in SAP.
- To assess the impact of Incident, Deviation, Change Control and CAPA.
- To participate in investigation of cGMP non conformances, Deviation, Market complaints and Incident for identification of root cause and implementation of identified CAPA.
- To ensure that batch must be manufactured and checked in compliance with laws in forced in that member state and in accordance with requirement of marketing authorization, registration dossier (ND).
- Any other job assigned time to time by HOD. To assure Quality and cGMP compliance of the products being manufactured and Packed for Penicillin Block.




- To review MMD-I / BPR and release of the batches for further processing stage like Granulation, compression, coating, inspection, filling and packing.
- To ensure IPQA functions and periodical verification of in- process parameter as per batch record and SOP.
- To review & impact assessment of break down intimation slip (BDIS) and to advise precautions to be taken before, during and after attending BDIS & Closure of BDIS.
- Ensure timely review of executed batch processing record and stage clearance for further activity.
- Review and approval of Master MMD-I & Batch packing record • To deliver the training for IPQA/Shop floor Team as per schedule and as when required.
- To participate in Regulatory/Internal Audit and cGMP review meeting and facilitate its compliance.
- Preparation, review and approval of SOP and ensure proper implementation at shop floor.
- Intermediate & final Release of Finished Product in SAP.
- To assess the impact of Incident, Deviation, Change Control and CAPA.
- To participate in investigation of cGMP non conformances, Deviation, Market complaints and Incident for identification of root cause and implementation of identified CAPA.
- To ensure that batch must be manufactured and checked in compliance with laws in forced in that member state and in accordance with requirement of marketing authorization,



registration dossier (ND).
- Any other job assigned time to time by HOD. To assure Quality and cGMP compliance of the products being manufactured and Packed for Rifampicin Block. To give area and machine clearance i.e. checking and approval of processing areas and Equipment's prior to start of batch processing. To verify environmental conditions i.e. Temperature, Relative Humidity & Differential Pressure conditions are within acceptable range in all areas. To perform and verify challenge tests at manufacturing and packing stages as per the pre-defined frequency. To verify the status of calibration and preventive maintenance of Equipments used in manufacturing and packing operations. To perform sampling of in- process, finished product and retain samples as per respective MMD-I / BPR/SOP. Process validation/Hold Time/Packing Validation/Stability study as per respective protocols and to submit the samples to Quality Control for analysis. To notify the change control / Deviation related to shop floor activities. To review MMD-I / BPR and release of the batches for further processing stage like Granulation, compression, coating, inspection, filling and packing. Review and approval of Master MMD I and BPR. To participate in the investigation of Deviation and Market Complaint for identification of root cause and implementation of identified CAPA. To review & impact assessment of break down intimation slip (BDIS) and to advise precautions to be taken before, during and after attending BDIS & Closure of BDIS. Any other job assigned time to time by HOD.

📌 Senior Executive (Dholka)
🏢 DigiCAD
📍 Dholka