ASSISTANT MANAGER

Department Details BPL QA Role Summary In-Process Quality Assurance (IPQA-OSD) Key Responsibilities The person with hands on IPQA experience will be considered. • To follow the GMP & GDP practices in daily production activities. • Responsible for Calibration or verification of IPQA instruments. • Performing the in-process Quality checks and cleaning of sampling aids. • Responsible for providing the Line clearance certification. • Online review of batch record at all stages of manufacturing and packing activities. • Sampling of in-process, process validation, cleaning validation, hold time, finished product, stability sample and retention samples. • Review and release / rejection of batch at in-process, intermediate and finished product stages of manufacturing of drug products and ensure the batch release or rejection SAP. • Preparation, review and approval of Process validation/optimization/ Hold time protocol and report. • Responsible for initiation and review of Change control/Deviation/ CAPA • Responsible for Preparation and review of APQR • Responsible for Review and approval of Production & Warehouse SOP's • Responsible for tracking of external calibration of IPQA Instruments • Performing equipment challenge test during process validation and batch execution Educational Qualifications Required Education Qualification: Required Experience: - years