Nagesh

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Director- Quality Assurance, Strides Pharma Inc., at Strides Inc.|Lambertville, New Jersey, United States

Position:

Director- Quality Assurance, Strides Pharma Inc., at Strides Inc.

Location:

Lambertville, New Jersey, United States

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Last updated: 2024-04-08
Updated: 2024-04-08

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Work Experience 31 years

Director- Quality Assurance, Strides Pharma Inc., at Strides Inc.

Oct 2012 - Current

Senior Manager- Quality Assurance at Jubilant Cadista Pharmaceuticals

Jun 2006 - Sep 2012

Group Leader - QA at Ohm Laboratories Inc./Ranbaxy Pharmaceuitcals Inc

Jan 2002 - Jun 2006

Group Leader- QA/QC at Dr Reddy`S Laboratories Limited

Jan 1995 - Jan 2001

Nagesh started working in 1995, then the employee has changed 3 companies and 3 jobs. On average, Nagesh works for one company for 7 years 8 months.

Their professional focus is 21 CFR Part 11, Abbreviated New Drug Application (ANDA), and Analytical Chemistry across 3 core areas.

Education

Master of Science (M.S.) at Andhra University

Skills

U.S. Food and Drug Administration (FDA), OQ, Cleaning Validation, Analytical Method Validation, Corrective and Preventive Action (CAPA), Verification and Validation (V&V), Quality System, Validation, 21 CFR Part 11, CAPA, SOP, V&V, Abbreviated New Drug Application (ANDA), SOP development, Regulatory Submissions, IQ, ICH guidelines, ANDA, LIMS, Gas Chromatography, HPLC, Training, Technology Transfer, cGMP practices, Dissolution, Vendor Qualification, USP, Pharmacovigilance, IND, Quality Management, Regulatory Affairs, Change Control, Regulatory Requirements, Standard Operating Procedure (SOP), Pharmaceutical Industry, SAP, Quality Auditing, Generic Programming, Compliance, GxP, GMP, Computer System Validation, Analytical Chemistry, cGMP manufacturing, FDA, Chromatography, GLP

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