Sushilkumar Giri
@sushilkumargiri
Experienced QA professional in pharmaceuticals ensuring regulatory compliance.
IndiaWhat I'm looking for
I am an experienced pharmaceutical quality assurance professional with over a decade of hands-on experience across QA, IPQA and lab QA roles. I have progressed from QA Officer roles to an Assistant Manager position, working in regulated manufacturing environments.
My work focuses on ensuring manufacturing compliance with national and international standards including FDA, USFDA, ISO, WHO-GMP and cGMP, and I have participated in and supported many party audits. I manage QMS activities such as APQR, change control, deviations, OOS investigations, vendor qualification and internal audits.
I routinely perform shop-floor IPQA duties covering cleanroom behavior, aseptic operations, dispensing, packaging and dispatch, and I review and prepare BMR/BPR and master documentation. I also develop and implement SOPs, deliver in-house training and maintain documentation practices.
I hold an M.Sc. in Analytical Chemistry and certifications in ISO 9001:2015, Fundamentals of Quality Assurance and Total Quality Management. I am comfortable with SAP 7.3, ERP, EDMS 1.0 and common office tools, and I bring a disciplined, audit-focused approach to quality systems improvement.
Experience
Work history, roles, and key accomplishments
QA Assistant Manager
Amoli Organics Pvt. Ltd.
Jun 2021 - Present (4 years 4 months)
Manage QA operations including QMS, audits, vendor qualification and documentation control, ensuring compliance with GMP/ISO/FDA standards and supporting continuous quality improvements since joining.
Senior QA Executive
Aarti Surfactants Ltd.
Aug 2020 - Jun 2021 (10 months)
Executed QA responsibilities including in-process IPQA, documentation (deviations, OOS), internal audits and compliance with national/international standards to maintain product quality.
QA & Lab QA Executive
Unimark Remedies Ltd.
Jan 2017 - Jul 2020 (3 years 6 months)
Performed QA and laboratory QA duties including review of BMR/BPR, sample testing oversight, internal audits and implementation of corrective actions to uphold regulatory compliance.
Research Associate
Macleods Pharmaceutical Ltd.
Dec 2015 - Dec 2016 (1 year)
Supported analytical method development and research activities in the AMD group, contributing to stability studies and method validation efforts for pharmaceutical products.
QA Officer
Ciron Drugs & Pharmaceutical Pvt. Ltd.
Nov 2011 - Nov 2015 (4 years)
Managed QA activities including process compliance, shop-floor IPQA, document control and preparation for external audits to ensure adherence to cGMP and quality standards.
Education
Degrees, certifications, and relevant coursework
UAUniversity of Allahabad
Master of Science, Analytical Chemistry
Completed M.Sc. (Analytical) at the University of Allahabad, focusing on analytical chemistry.
Ishwar Sharan Degree College, University of Allahabad
Bachelor of Science, Chemistry
Completed B.Sc. with a major in Chemistry at Ishwar Sharan Degree College under the University of Allahabad.
Joshibaug College
H.S.C., Higher Secondary
Completed Higher Secondary Certificate (H.S.C.) from Joshibaug College under the Mumbai Board.
Century Rayon High School
S.S.C., Secondary Education
Completed Secondary School Certificate (S.S.C.) from Century Rayon High School under the Mumbai Board.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
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