Assistant Manager
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).• 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 Equipment’s 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 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.
• Intermediate & final Release of Finished Product in SAP.
• 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.
• 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.
• Retain sample management and executed batch document
• To ensure terminal Inspection of finished goods for export market dispatched from Dholka.
• Responsible for Terminal Inspection of finished goods for export market dispatched from Dholka.
• Responsible for terminal inspection of all LL products.
• Responsible for sampling of all LL products for QC testing and retain sampling for LL Products.
• Responsible for Retain sample management for MPB, Rifampicin, Herbal, and LL Products.
• Responsible for executed BMR management.
• Responsible to prepare Certificates of Conformance, Declaration and Approval letters as per requirement.
• Responsible for timely perform periodical observed of retain sample.
• Responsible to send BMR/BPR as per requirement of country wherever required.
• Any job assigned time to time by seniors.