BNBipindra Singh Negi
@bipindrasinghnegi
Quality-focused Analytical QA/QC Manager with 19+ years in pharmaceuticals.
IndiaWhat I'm looking for
I am a meticulous, compliance-focused Quality Assurance & Control professional with over 19 years of experience in the pharmaceutical industry, leading integrated Lab-QA, QC, and Analytical Development Laboratory operations and ensuring adherence to global regulatory standards.
I have a proven record of managing QMS events, data integrity (ALCOA+), analytical method validation, instrument qualification, and successfully addressing regulatory audits while driving CAPA implementation and improving audit readiness.
Experience
Work history, roles, and key accomplishments
Manager Analytical QA/QC
Nixi Laboratories Private Limited
Sep 2023 - Present (2 years 2 months)
Headed Lab-QA, QC and ADL operations ensuring cGMP and data integrity; led investigations (OOS/OOT/deviations), instrument qualifications (IQ/OQ/PQ) and closure of audit observations since joining.
Dy. Manager QA / Lab-QA
Troikaa Pharmaceutical Limited
Jul 2015 - Mar 2022 (6 years 8 months)
Managed Lab-QA activities ensuring SOP compliance and ALCOA+ data integrity; reviewed QMS events and supported regulatory audits and observation closures between 2015 and 2022.
Assistant Manager QC
Akums Drugs & Pharmaceuticals Limited
Jul 2014 - Jul 2015 (1 year)
Managed routine HPLC analyses, compiled analytical data and handled laboratory incidents and audits during tenure.
Senior Executive QC
Windlas Healthcare Limited
Dec 2012 - Feb 2014 (1 year 2 months)
Managed stability study analyses and documentation, supported ANDA filings and performed method validation and instrument troubleshooting.
Executive QC
Mankind Pharma Limited
Sep 2011 - Oct 2012 (1 year 1 month)
Handled sample intake, analysis planning and data review for RM/PM/IP/FP and stability samples, and participated in internal and regulatory audits.
Sr. Officer QC
Elder Pharmaceuticals / Rusan Pharma
Jun 2009 - Sep 2011 (2 years 3 months)
Performed routine sample analyses, instrument calibration and documentation; participated in new lab setup and maintained GLP practices.
Chemist / Sr. Chemist QC
Wockhardt / Windlas Biotech
Jul 2005 - May 2009 (3 years 10 months)
Conducted routine HPLC/GC analyses, prepared working standards and upheld GLP practices across QC operations.
Education
Degrees, certifications, and relevant coursework
MUMadhya Pradesh Bhoj (Open) University
Master of Science, Chemistry
Completed postgraduate studies in chemistry focusing on advanced analytical and theoretical concepts applicable to pharmaceutical quality control.
HUHemwati Nandan Bahuguna Garhwal University
Bachelor of Science, Physics, Chemistry & Mathematics
Completed undergraduate studies in physical, chemical, and mathematical sciences with emphasis on foundational concepts for analytical work.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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