Sagar Botre

Background

About Sagar Botre

Presently Working in Cipla Pharmaceuticals Ltd. at Goa Unit-I Sterile Formulation from sep-2019 to Till Date as an Sr. Executive in Quality Assurance Department CURRENT JOB PROFILE-Monitoring in-Process Control checks, Review of batch packing record and batch manufacturing records, log books as per standard operating procedure and batch record instructions to meet the cGMP requirement-Ensure line clearance of area like packing, vial washing, filling, autoclave loading, manufacturing area as per respective area checklists and SOP-Monitoring quality operation to ensure compliance to the cGMP standards-Visual assessment of aseptic manufacturing and filling process-Taking quality observation rounds of packing, filling, service floor, stores etc. And reporting observed non-conformance during round-Participating in media fill batches-Review Of executed batch manufacturing, filling, packing records-Data logger setting(temprecord) and final report compilation-Performing audit trail of assigned equipment’s- Participating in investigation of any non-conformance observed in manufacturing and packing area-Conducting unit operation of all SOP related to packing and manufacturing activity-Carry out in process test and challenge test related to batch filling and packing-Finish product sampling-Preparation, Review and Implementation of Master BMR and Master BPR-Responsible for preparation, review and implementation of SOP’s, formats/logs to meet cGMP-Retention and destruction of documents and records as per SOP-Batch Overprinting details checking along with Standard Specification Details-In Cipla, USFDA, MHRA Audit faced as support team and for providing documents and I faced below regulatory audits during my tenure period in Cipla. • Germany • Sandoz • FDA -Compilation and Release the batches as per the SLA -Handling and review of non-conformance investigation report at shop floor and during process -Handling of SAP, E- Log, E- Track, Cipdox activity as per QA role -Handling of SAP, E- Log, E- Track, Cipdox activity as per QA role