Sanjeev Kumar
Extensive experience (about 24 years) in Quality (QA & QC) management, cGMP manufacturing of FDA-regulated APIs, and Formulation... | Bharuch, Gujarat, India
*50 free lookup(s) per month.
No credit card required.
Sanjeev Kumar’s Emails sa****@ya****.co
Sanjeev Kumar’s Phone Numbers No phone number available.
Social Media
Sanjeev Kumar’s Location Bharuch, Gujarat, India
Sanjeev Kumar’s Expertise Extensive experience (about 24 years) in Quality (QA & QC) management, cGMP manufacturing of FDA-regulated APIs, and Formulation Units. Strong expertise in Vendor and working partners audits (about 200 API, Formulations, Packing material manufacturing units in India, Europe, China) Validation, scale-up, stability study of Drug products and API(s) Training focusing on continuous improvement. Managed up to 140 professional QA / QC staff in routine operations. Managed multi locations of Formulations and API plants. Skills: cGMP Manufacturing at FDA-approved plants Hosted FDA/EU/TGA/MHRA inspections (over 18) Vendor Audits (over 200) Aseptic/sterile processing of API / Formulations ( Injectable & Eye drops) Liquid/solid oral dosage forms (Syrup, Suspensions, Tablets, capsules, Powders, Creams Lotions) Training on CFR / ICH/ EU guidelines Handling of CAPA, Deviation, OOS, Change Control Quality Risk Management Trainer for Total Quality Management (TQM) I have hosted over 18 inspections by the USFDA, MHRA, TGA, ANVISA/ MCC / QP and EU Regulatory Agencies for Formulations and API manufacturing units, resulting into none to few major observations, besides vendor qualification teams of many national & international companies I have adequate experience of transforming semi regulated to regulated manufacturing units for API and formulations. Establishing to a quality system complying with US / EU regulatory requirements. Reviewing and submission of 29 DMF(s). Coordinated closely with a lot of reputed international Consultants.
Sanjeev Kumar’s Current Industry Amneal
Sanjeev
Kumar’s Prior Industry
Aristo Pharmaceuticals
|
Ipca Laboratories
|
Glenmark Pharmaceuticals
|
Sun Pharmaceutical Industries
|
Aurobindo Pharma
|
Dr Reddys Laboratories
|
Alkem Laboratories
|
Neuland Laboratories
|
Amneal
Not the Sanjeev Kumar you were looking for?
Find accurate emails & phone numbers for over 700M professionals.
Work Experience
Amneal
Associate Vice President - Qa
Thu Oct 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Neuland Laboratories
Vice President - Quality & Regulatory
Thu May 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Oct 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Alkem Laboratories
Associate Vice President - Quality
Sun Jul 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu May 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Dr Reddys Laboratories
Associate Director - Global Quality
Fri Sep 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Aurobindo Pharma
Sr. Manager
Thu Sep 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Sep 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Sun Pharmaceutical Industries
Sr. Manager - Quality Control, Assurance & Regulatory
Sat Dec 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Sep 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Glenmark Pharmaceuticals
Manager - Quality Control
Tue May 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Dec 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)
Ipca Laboratories
Assistant Manager - Quality
Mon Apr 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Apr 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)
Aristo Pharmaceuticals
Quality Control & Assurance Executive
Fri Nov 01 1991 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Apr 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Sanjeev Kumar Email Addresses
FAQ About Sanjeev Kumar
-
Sanjeev Kumar is located at
Bharuch, Gujarat, India -
Sanjeev Kumar is a
Extensive experience (about 24 years) in Quality (QA & QC) management, cGMP manufacturing of FDA-regulated APIs, and Formulation Units. Strong expertise in Vendor and working partners audits (about 200 API, Formulations, Packing material manufacturing units in India, Europe, China) Validation, scale-up, stability study of Drug products and API(s) Training focusing on continuous improvement. Managed up to 140 professional QA / QC staff in routine operations. Managed multi locations of Formulations and API plants. Skills: cGMP Manufacturing at FDA-approved plants Hosted FDA/EU/TGA/MHRA inspections (over 18) Vendor Audits (over 200) Aseptic/sterile processing of API / Formulations ( Injectable & Eye drops) Liquid/solid oral dosage forms (Syrup, Suspensions, Tablets, capsules, Powders, Creams Lotions) Training on CFR / ICH/ EU guidelines Handling of CAPA, Deviation, OOS, Change Control Quality Risk Management Trainer for Total Quality Management (TQM) I have hosted over 18 inspections by the USFDA, MHRA, TGA, ANVISA/ MCC / QP and EU Regulatory Agencies for Formulations and API manufacturing units, resulting into none to few major observations, besides vendor qualification teams of many national & international companies I have adequate experience of transforming semi regulated to regulated manufacturing units for API and formulations. Establishing to a quality system complying with US / EU regulatory requirements. Reviewing and submission of 29 DMF(s). Coordinated closely with a lot of reputed international Consultants. Amneal -
Sanjeev Kumar currently works in the
Amneal -
Sanjeev Kumar specializes in
Extensive experience (about 24 years) in Quality (QA & QC) management, cGMP manufacturing of FDA-regulated APIs, and Formulation Units. Strong expertise in Vendor and working partners audits (about 200 API, Formulations, Packing material manufacturing units in India, Europe, China) Validation, scale-up, stability study of Drug products and API(s) Training focusing on continuous improvement. Managed up to 140 professional QA / QC staff in routine operations. Managed multi locations of Formulations and API plants. Skills: cGMP Manufacturing at FDA-approved plants Hosted FDA/EU/TGA/MHRA inspections (over 18) Vendor Audits (over 200) Aseptic/sterile processing of API / Formulations ( Injectable & Eye drops) Liquid/solid oral dosage forms (Syrup, Suspensions, Tablets, capsules, Powders, Creams Lotions) Training on CFR / ICH/ EU guidelines Handling of CAPA, Deviation, OOS, Change Control Quality Risk Management Trainer for Total Quality Management (TQM) I have hosted over 18 inspections by the USFDA, MHRA, TGA, ANVISA/ MCC / QP and EU Regulatory Agencies for Formulations and API manufacturing units, resulting into none to few major observations, besides vendor qualification teams of many national & international companies I have adequate experience of transforming semi regulated to regulated manufacturing units for API and formulations. Establishing to a quality system complying with US / EU regulatory requirements. Reviewing and submission of 29 DMF(s). Coordinated closely with a lot of reputed international Consultants. -
Sanjeev Kumar speaks the following languages:
No languages available. -
Sanjeev Kumar has prior experience in the following industries:
Neuland Laboratories , Alkem Laboratories , Dr Reddys Laboratories , Aurobindo Pharma , Sun Pharmaceutical Industries , Glenmark Pharmaceuticals , Ipca Laboratories , Aristo Pharmaceuticals -
Sanjeev Kumar has the following professional experience:
Amneal , Neuland Laboratories , Alkem Laboratories , Dr Reddys Laboratories , Aurobindo Pharma , Sun Pharmaceutical Industries , Glenmark Pharmaceuticals , Ipca Laboratories , Aristo Pharmaceuticals . -
You can view Sanjeev Kumar’s
LinkedIn profile at LinkedIn URL. -
Sanjeev Kumar’s work email addresses are
[email protected] . -
Sanjeev Kumar works at
Amneal
People you may be interested in
- Ieda Maria Trombino
- Joseph Burns
- Rebecca Vaughn
- Dave Tracey
- Hery Rahmad
- Tiffany Shivers Ms
- Tarsem Rajput
- Ekaterina Verbitskaya
Serviço de Nutrologia Responsável Técnica e Chefe Serviço de Medicina Hiperbárica Santa Casa de Misericórdia de Santos
Independent Computer Networking Professional
Spine Consultant at Medtronic Biological and Sciences
UK&I Microsoft Alliance Manager
Warehouse & Inventory Management
Education, Development, and Fundraising Professional
Area Sales Head- Indiabulls Housing Finance Limited
Administrator BearingPoint