Available to hire
I am an experienced QA Associate II with expertise in injectables, biosimilars, and vaccines. I have supported regulatory audits by US FDA, MHRA, EU-GMP, and ANVISA, and I thrive in cross-functional, quality-driven environments. I enjoy optimizing processes from upstream to packaging and helping teams maintain rigorous compliance with safety and quality standards.
In my roles, I have led QA activities, performed data analysis, reviewed GMP documentation, and contributed to trackwise QMS investigations. I value clear communication, meticulous documentation, and continuous improvement to ensure product quality and regulatory readiness.
Skills
Experience Level
Expert
Expert
Expert
Intermediate
Intermediate
Intermediate
Intermediate
Intermediate
Intermediate
Language
English
Fluent
Marathi (Marāṭhī)
Fluent
Hindi
Fluent
Work Experience
QA Associate II at Baxter Pharmaceutical Pvt Ltd
June 1, 2024 - PresentIP QA activities in Process, Visual Inspection (Manual and Automatic) and Packaging; GMP documentation revisions of SOPs, BMR and BPR; BMR and BPR review for Batch Release; LabVantage LIMS, IDBS ELN, mini-tab data analysis; user management and periodic audit trails of manufacturing equipment; TcU (Team Center) documentation; TrackWise QA support for change controls, NCR/NCR, CAPA, and QMS investigations.
QA Associate II at Baxter Pharmaceutical Pvt Ltd, Ahmedabad
June 1, 2024 - PresentIP QA activities in Process, Visual Inspection (Manual and Automatic) and Packaging; GMP documentation revision of SOP, BMR and BPR; BMR and BPR review for Batch Release; LabVantage LIMS, IDBS ELN, MiniTAB data analysis; User management and periodic Audit trail of manufacturing equipment; Documentation in Team Center, CFSE LN log book review, QMS support for TrackWise; Review of change controls, NCR/SNCR, CAPA, and effectiveness checks.
IP QA Chemist (Vaccine DS and DP) at Gland Pharma Ltd
July 1, 2021 - May 20, 2024Across upstream/downstream, formulation, filling of SAN (vaccine DS/DP); Single Use System like Wave Bioreactor, Cytiva XDR Bioreactor, AKTA chromatography line clearance; Review of process validation protocols, cleaning validation protocols and reports; SOP review, collection and submission of samples; Shop floor rounds, change controls, deviation, and CAPA activities and QMS investigations.
IP QA Chemist (Vaccine DS and DP) at Hyderabad Grand Pharma Ltd
July 1, 2021 - May 1, 2024Overseas IP QA across upstream and downstream, formulation, and filling of Sputnik vaccine; ensured QA compliance across manufacturing steps; supported regulatory audits; contributed to process validation, equipment commissioning, and CAPA activities.
IP QA Chemist (Vaccine DS and DP) at Gland Pharma Ltd, Hyderabad
July 1, 2021 - May 31, 2024Oversee IP QA across upstream, downstream, formulation, and filling of Sputnik vaccine; Single Use System like Wave Bioreactor, Cytiva XDR Bioreactor, AKTA chromatography; Review process validation protocols, cleaning validation protocols and reports; SOP review, collection and submission of samples; Shop floor counters, change controls, deviation, incident and CAPA activities and QMS investigations.
Career Break at Self (UPSC Preparation)
October 1, 2015 - June 30, 2021Full-time UPSC preparation and related studies.
UPSC Preparation (Career Break) at Pune
October 1, 2015 - June 1, 2021Full-time UPSC exam preparation (career break).
Full-time UPSC Preparation at Self-Employed
October 1, 2015 - June 30, 2021Focused on UPSC civil services preparation; developed strong writing skills and analytical thinking.
Quality Assurance at Reliance Life Sciences Ltd, Navi Mumbai
August 20, 2014 - September 20, 2015Dispensing, Upstream, Downstream, Formulation, Filling and Packaging activities in DS and DP; Reviewed GMP documents; Supported regulatory audits and handled batch release documentation in PharmaArea, LAWBare LIMS; Ensured data integrity (ALCOA+).
Quality Assurance - Biosimilars at Reliance Life Sciences Ltd, Navi Mumbai
August 1, 2014 - September 30, 2015Dispensing, Upstream, Downstream, Formulation, Filling and Packaging activities in Drug Substance (DS) and Drug Product (DP); Review GMP documents; Supported regulatory audits and handled batch release documentation in PharmaReady, LabWare LIMS.
Education
Integrated M.S./M.Tech Biotechnology at Institute of Bioinformatics and Biotechnology, Savitribai Phule Pune University (SPPU), Pune
August 1, 2008 - July 1, 2014Higher Secondary (HSC) - CBSE at Jawahar Navodaya Vidyalaya, Solapur
May 1, 2007 - June 30, 2008Integrated MS/MTech Biotechnology at Institute of Bioinformatics and Biotechnology, SPPU, Pune
August 1, 2008 - July 1, 2014M.S./M.Tech Biotechnology at Institute of Bioinformatics and Biotechnology, SP Pune University (SPPU), Pune
August 1, 2008 - July 1, 201412th Standard (HSC/ CBSE Board) at Jawahar Navodaya Vidyalaya, Solapur
May 1, 2007 - June 1, 2008Master of Science / Master of Technology in Biotechnology at Institute of Bioinformatics and Biotechnology, Savitribai Phule Pune University (SPPU), Pune
August 1, 2008 - July 1, 2014Diploma in Intellectual Property Laws at Symbiosis Law School
July 1, 2013 - July 1, 2014Qualifications
Patent Law & Global Public Health
December 20, 2024 - June 24, 2026Advanced Cell Therapy Technology
December 1, 2024 - June 24, 2026Diploma in Intellectual Property Law
December 1, 2022 - June 24, 2026Advanced Cell Therapy Technology
December 1, 2024 - June 24, 2026Diploma in Intellectual Property Laws
December 1, 2022 - June 24, 2026Patent Law & Global Public Health
December 1, 2024 - June 24, 2026Patent Law & Global Public Health
January 1, 2024 - June 24, 2026Diploma in Intellectual Property Laws
December 20, 2022 - June 24, 2026Advanced Cell Therapy Technology
December 20, 2024 - June 24, 2026Advanced Cell Therapy Technology
December 20, 2022 - June 24, 2026Patent Law & Global Public Health
December 20, 2024 - June 24, 2026Diploma in Intellectual Property Laws
July 1, 2013 - July 1, 2014Industry Experience
Life Sciences, Healthcare, Manufacturing, Professional Services, Education
Skills
Experience Level
Expert
Expert
Expert
Intermediate
Intermediate
Intermediate
Intermediate
Intermediate
Intermediate
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