Tear ster late ee ra eee” MeL cal CORE COMPETENCIES @ executive PROFILE Quality Assurance /Quality Control Batch Release & Stability Audit & Compliance Change Control/Deviation/OOS Lab ware LIMS,SAP,NOVA LIMS Document ‘Author/Reviewer/Approver Quality Risk Management Training & Development DS, DP,Stability,Raw material, Packing material and In process —_ > > ie y SOFT SKILLS Gritical Thinker, Communication © M.Sc. offering rich experience with 18 years of successful career in Quality Assurance & Quality Control of Pharmaceutical industry (Small ‘molecules, Large molecules and Biologicals). ‘© Insightful knowledge of all dependent functions of QA,QC,Packing, raw ‘material, Warehouse,Regulatory Affairs,RnD, Quality Management Systems, compliance & so on © Experience in handling of investigations to find out root cause in Deviation, Laboratory Incidents, OOS/OOT/OOC Water sample! excursions, Calibrations & Qualification failure, Batch Failure, Rejections & Market Complaints. © Expert in QMS, Trackwise, Root cause analysis, CAPA identification, review and tracking, change & quality risk assessment, Audit as member to facing auaitor's system design & implementation, © Subject Matter Expert in Stability Management, Analytical & Raw and Packing ‘material LIMS implementation and SAP © Capability in conducting Shop floor inspection, internal audits including finding solutions to compliance gaps identification, ‘© Excellent knowledge on regulatory requirements, GDP, GAMP 5, 21 CFR part 11 and cGMP. Detailed oriented mindset with a focus on quality and compliance. ‘+ Knowledge in cGMP and GLP, Communication and coordination skills, Effective time management and Leadership as well a team working ability (il auprrs Analytical, leadership ® Audits Faced: Requiatory audits of INDIA, USFDA, PMDA, EU GMP, WHO, &Teamwork EB rarer EP rotlem sting skills 1 EDUCATION & CREDENTIALS M.Sc (Organic Chemistry) In Second division from Dr.B.A.Marathwada University Aurangabad (MS) in 2006 B.Sc (Organic Chemistry) In Second division from ASC Collage Panvel, Mumbai University (MS) in 2003 Canada, MHRA & muttiple customer aucits ‘© Recognition & appreciation for the work towards successful accomplishment of regulatory audits 717 SKILLS + Operating System : Windows (any versions) & MS Office, SharePoint, Basics of Power Bi ‘+ Instrument & Software: Trackwise,Lab ware LIMS, SAP,NOVA LIMS, all major QC software, © ACCOMPLISHMENT ‘+ Recognition & appreciation of the work towards successful accomplishment of regulatory audits. ‘+ Awarded as “Go Geter’ towards fulfiling functional goals & organizational goals for at Biocon. ‘+ Received Bravo and Spartan award for stability batches release within time line, + Rated Exceeds Expectation during appraisal cycles for consecutive 3 years at APOTEX34 AUG 2020 TO TILL DATE Biocon Biologics Ltd. Bengaluru as Deputy Manager - Quality Assurance Department Current Role: Part of Analytical Quality Assurance engaged in Biosimilars (Bmab 1000, 1200 and 1800) Review of Finished product process tabilty Raw and packing material data and involving is batch release activity through LIMS and SAP. Review of Quality Control documents (Specifications, SOP, STP ,CoA, Study protocol, Characterization & testing reports of Reference stadards etc.,) that supports testing of Analytical, Finished products, In-process, Raw material, Packing material, Medical Devices. Review and approval of stablity annul trend report and water testing quarter and annual trend report. Review of RnD documents like Technology Transfer Documents, Justification of Specification etc, ‘SME in management of Events (Deviations & Incidents), OOS/OOT/OOC, & CAPAS,Risk assessment report and Change Requests related to GMP sections like QC- Anaiytical, Stability ,Raw material and Packing etc, Involving in Stability sample inception, physical verification and approval in NOVA LIMS Software. Interaction with partners and clarifying queries for smooth moving of activities. Driving QMS improvement initiatives to make quality easy with both simplicity & compliance in mind. Subject Matter Expert in Stablity Management, Site & Global QC & QA SOPs, Aucit tral review, Preparation/Presentation of Periodic trends of QMS elements, Escalation notifications, Management review meeting. 12" JAN 2015 to JULY 2020 ‘Apotex Pharma chem India (P) Ltd Bengaluru As Assistant Manager -Quality Control & Quality Assurance Key Result Areas: Review of all Quality control documents like in process, Raw material, finished product, Working standards and Stability along with its electronic data and Audit trails forall chromatographic and non chromatographic data Review of all GLP Documents like calibration documents of HPLC, GC, UV, IR, polari meter etc... Review of all reports, daily Calibrations of Balance, PH, conductivity meter and KF standardization through LIMS “imparting SOP training to QC based on the identified needs, Revision SOP'S Related to Quality Control. Trending of OOS, OOT and LIR’s. Investigation Laboratory Incidences, deviations, 00S,OOT along with investigator. Review of Working Standard and Qualification documents. Responsible to Maintain Laboratory Management System as per the GLP requirement. 417th JAN 2013 to 8" JAN 2015 Cipla Ltd, Bengaluru As Lab QA Revewer Key Result Areas: Review of reports like in process, API, Intermediates, Raw material, packing material, stability reports, cleaning validation reports ‘andall instruments calibration reports, working standards, test standards protocol and reports Investigation of any incidence, Deviation, 00,007 and OC or error occurred GLP rounds as per schedule 23rd JULY 2008 to 8th DEC 2012 Cipla Ltd, Patalganga (Maharashtra) As Quality Control Officer (Section finished product (API)) Key Result Areas: ‘Analysis of API, In process, Intermediate, stabilty sample Handling of instruments such as HPLC water Alliance Empower, GC-Perkin Elmer, UV-Spectrophotometer Shimadzu, FTIR Perkin Elmer, Kar-fisher Auto titrtor, Coulometer- Metrofim, pH meter -Lab India, Melting point Apparatus optimett Polar meter Rudolph Research analytical, Tab Density Tester Electro lab, Potentiometer Lab Incia etc. Prepared ATR (Analytical test report through TQC software) ‘Analysis of Process validation, cleaning validation of products, 24** AUG 2006 to 20% JULY 2008 Indoco Remedies Ltd, Patalganga (Maharashtra), As Junior Officer (Quality control) Key Result Areas: ‘Sampling of RAW material, Finish product and Intermediates Analysis of API, In process, Intermediate, stability sample Handling Of instruments such as HPLC, GC, Potentiometer, FTIR, UV-Spectrophotometer PERSONAL DETAIL Permanent Address _: C/o Kaveriappa C K Nagar 13% cross, Hossa Road Bengaluru-560100 Language known English, Hindi, Kannada Marathi