Bharath Begane

Experience

• 

  Hikal Ltd

  Dec 2010 - Apr 2011

  Officer

  Production Operations

• 

  Apotex Pharmachem India Pvt. Ltd

  Nov 2011 - Apr 2014

  Research Associate - 1
• 

  Biocon

  Dec 2014 - Sept 2016

  Quality

  Quality compliance operations

• 

  TCG Lifesciences Pvt Ltd.

  Sept 2016 - now

  Assistant Manager

  • Review and approval of Production, Quality control, Warehouse, Maintenance documents related to testing and manufacturing of Pharmaceutical Finished products/API/Intermediates/Raw materials/Packing Materials • Review and approval of Analytical Method Validation, Cleaning Method Validation, Analytical Method Transfer, Computer System Validation protocols and reports.• Preparation, review and approval of functional/cross-functional SOPs.• Handling of Quality elements (QMS) such as, Change Control Management. Deviation Management. Root Cause Analysis. Risk Assessment and CAPA.• Review, Investigation and approval of OOS/OOT results, Laboratory incident reports.• Review and approval of Quality control documents such as Batch release analytical data, Method Validation data, Working standard qualification reports, STPs etc.• Review and approval of production documents such as BPCR, LDR, Process Validation/Equipment holding study/Cleaning Validation protocol/report, material reconciliation etc.• Issuance and control of BPCRs, STPs, SOP, Analytical raw data sheets, calibration schedules etc.• Verification of Line clearance from batch to batch.• Review and approval of qualification documents such as DQ, IQ, OQ, PQ for instrument/equipment/area/ software qualification protocol and reports. • Preparation of Annual product quality review and trend reports of all quality related events.• As a part of Quality Assurance, accompanies with QC, Production and Warehouse to investigate the OOS and deviation results.• Vendor audit execution and approval of vendor site for various Intermediates/Key starting materials, Raw materials and external analytical services.• Execution of Internal audit on scheduled basis and escalation to management regarding major non-compliance at production, QC, warehouse etc.• Verification of system audit trail of Empower 3 software. Show less