Job Description

To perform In-process Quality Assurance for the process / products being manufactured and packed in Main Pharma Block (Tablet / Capsule). To ensure Quality and cGMP compliance of the products being manufactured and Packed in Main Pharma Block (Tablet/Capsule). o To give area and machine clearance i.e. checking and approval of processing areas and Equipment's prior to start of batch processing. o To verify environmental conditions i.e. Temperature, Relative Humidity & Differential Pressure conditions are within acceptable range in all areas. o To perform and verify challenge tests at manufacturing and packing stages as per the pre-defined frequency. o To verify the status of calibration and preventive maintenance of Equipment's used in manufacturing and packing operations. o 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. o To notify the change control / Deviation related to shop floor activities. o To review MMD-I / BPR and release of the batches for further processing stage like Granulation, compression, coating, inspection and packing. Review and approval of Master MMD-I and BPR. o To participate in the investigation of Deviation and Market Complaint for identification of root cause and implementation of identified CAPA. o Intermediate & final Release of Finished Product in SAP. o 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. o 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). o Any other job assigned time to time by HOD. 1. Planning and execution of Validation, Qualification, Re-Qualification and Re-Validation activities pertaining to Manufacturing facility at Dholka site in line with the cGMP requirements of national and international regulatory authorities. 2. To Perform Vendor Management Activity to assure that Vendors are Complying with Cadila SOP on Vendor Management and GMP Requirements in Order to source Quality Materials and Products. 3. To perform the validation exercises of new as well as existing equipment's, utilities and critical systems. 4. Preparation, Execution, Compilation & Review of qualification and Validation Protocols & Reports. 5. Preparation of SOPs pertaining to qualification and Validation activities. 6. To prepare and update Annual Validation Master Planner and Equipment Matrix of all Blocks. 7. To prepare, review, execute and compile the protocol and report of Transportation Validation. 8. To Performed FAT(Factory Acceptance Test), SAT(Site Acceptance Test). 9. Coordination with cross functional teams for smooth conduction of validation activities with respect to: o Equipment Qualification / Re-Qualification, Validation / Re-Validation o HVAC System Validation and Utility Validation o Temperature Mapping Study of critical area 10. To initiate and review change control, deviation and CAPA 11. To prepare, review protocol and reports and execute activity related to Aseptic Process Simulation (Media fill) Studies 12. Any other jobs assigned from time to time. To assure Quality and cGMP compliance of the products being manufactured and Packed for Cephalosporin Block. o To review MMD-I / BPR and release of the batches for further processing stage like Granulation, compression, coating, inspection, filling and packing. o To ensure IPQA functions and periodical verification of in- process parameter as per batch record and SOP. o 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. o Ensure timely review of executed batch processing record and stage clearance for further activity. o Review and approval of Master MMD-I & Batch packing record o To deliver the training for IPQA/Shop floor Team as per schedule and as when required. o To participate in Regulatory/Internal Audit and cGMP review meeting and facilitate its compliance. o Preparation, review and approval of SOP and ensure proper implementation at shop floor. o Intermediate & final Release of Finished Product in SAP. o To assess the impact of Incident, Deviation, Change Control and CAPA. o To participate in investigation of cGMP non conformances, Deviation, Market complaints and Incident for identification of root cause and implementation of identified CAPA. o 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). o 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. o To review MMD-I / BPR and release of the batches for further processing stage like Granulation, compression, coating, inspection, filling and packing. o To ensure IPQA functions and periodical verification of in- process parameter as per batch record and SOP. o 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. o Ensure timely review of executed batch processing record and stage clearance for further activity. o Review and approval of Master MMD-I & Batch packing record o To deliver the training for IPQA/Shop floor Team as per schedule and as when required. o To participate in Regulatory/Internal Audit and cGMP review meeting and facilitate its compliance. o Preparation, review and approval of SOP and ensure proper implementation at shop floor. o Intermediate & final Release of Finished Product in SAP. o To assess the impact of Incident, Deviation, Change Control and CAPA. o To participate in investigation of cGMP non conformances, Deviation, Market complaints and Incident for identification of root cause and implementation of identified CAPA. o 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). o 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. o To perform vendor management activity to assure that vendors are complying with Cadila procedure on vendor management and GMP requirements in order to source quality materials and products. o To perform self-inspection activity to assure that the facility remains in the state of cGMP compliance, to evaluate and identify gaps for future needs and to regularly review the effectiveness and applicability of the quality assurance system. o Responsible to assist for handing of day to day activities related to Vendor Approval. o To assist for evaluation of vendor documents and maintain current status. o To assist for preparing vendor grading of RM/PM based on rejection of supply from vendors on yearly basis. o To assist for providing required documents of vendor to cross functional team. o To assist for transfer of RM/PM stock in SAP, due to on-line rejection. o To assist for submission of the vendor samples to QC and maintain log of Sample Register. o To assist for intimation of RM/PM rejection to purchase department for CAPA and maintenance of RM/PM rejection tracking Sheet. o Responsible to assist for create & update of Raw Material & Packing Material vendors in SAP. o To perform vendor audits for vendor qualification as per requirement of RM/PM. o To maintain quality agreements with manufacturers and contract manufacturing parties. o To prepare and review of Site Master File and Quality Manual. o To prepare and review of excipients risk assessments. o Handling of Quality Management system (QMS). o To co-ordinate and perform the Self-inspection activity at the Site. o To prepare auditors list for self-inspection activity and conduct training program for auditors. o To prepare audit report, review compliance report, logbook updation, follow-up for the CAPA and to ensure effective implementation of CAPA. o Preparation, Review, Issuance, Revision, Control and Retrieval of SOP pertaining to functioning of the department. o To assist for any other jobs assigned from time to time by HOD.

Skills Required