Suneel Chhatre
Executive Director of Quality @Lupin
Signup · Get unlimited contacts
WORK HISTORY
Executive Director of Quality @Lupin
Somerset, NJ, US
Site Quality and Compliance Head overseeing Somerset site and US operations
EDUCATION
Ravishankar University
Master of Science (MS), Zoology; Cytogenetics; Chemistry
Indian Institute of Technology, Roorkee
Ph.D., Biochemistry & Microbiology
SKILLS
ABOUT SUNEEL CHHATRE
Quality Assurance functions in GMP regulated pharma & health care industry along with Regulatory, Compliance and related functions- Management of QC Analytical & Microbiology laboratories, cGxP testing of product/services, facility support- CLIA certified Director, Certified Auditor for ISO9001:2008- Certified Professional Chemist & Chemical Engineer (CPC/ChE)- Fellow of American Institute of Chemists (FAIC)- Certified in Molecular Diagnostic Technology (MDxT(AAB))- Adjunct Professor of Chemistry & Cell BiologyGMP experience: Supervising/managing GMP analytical laboratories in quality control testing per USP/FDA regulations; background in medical devices, generics, extended-release and immediate-release products; support GMP method specification development and approval; analysis pertaining to content, assay, bioburden, endotoxin, LAL, container/packaging testing, API and raw material release, impurity testing, analytical method validation, process validation, equipment validation, OOS/OOT events, particle size determination, loss on drying; conduct of audits of suppliers and vendors, extensive experience in aspetic manufacturing & ISO clean room monitoring CLIA/CAP experience:GLP experience: CAPA/laboratory investigations/deivations; internal and external GLP audits; conduct study, data, report, facility and process audits for GLP compliance; establish procedures and audit tools, CLIA certified Lab Director. Extensive experience in running a reference diagnostic laboratory as Lab Director & Technical Supervisor in Hematology, Endocrinology, Clinical Chemistry, Cytology & Molecular Diagnostics; Specialties: Mcrobiology, Molecular Biology, Clinical Chemistry, OOS Investigations, CAPA, Audits, ISO9001, FDA Title 21CFR Part 820, 11, CLIA Inspection, Analytical Chemistry, Pain Management, Supervision of Diagnostic & QA Labs (CLIA, CAP, ISO 9001, ISO 15189, QSR, Molecular Diagnostics, GCP, GMP, GLP, Part 11; Development of Quality Management System)
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.