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Sanjeev Kumar Email & Phone Number

Rtd - Associate Vice President - QA, Amneal at Ruban Memorial Hospital
Location: Bharuch, Gujarat, India 11 work roles 3 schools
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Current company
Role
Rtd - Associate Vice President - QA, Amneal
Location
Bharuch, Gujarat, India
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Sanjeev Kumar is listed as Rtd - Associate Vice President - QA, Amneal at Ruban Memorial Hospital, a with 12 employees, based in Bharuch, Gujarat, India. AeroLeads shows a matched LinkedIn profile for Sanjeev Kumar.

Sanjeev Kumar previously worked as Head of Supply Chain Management at Ruban Memorial Hospital and Head of Supply Chain Management at Ruban Memorial Hospital. Sanjeev Kumar holds Bachelor Of Pharmacy (B.Pharm.), Pharmacy, Ist - Class. from Lalit Narayan Mithila University.

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Ruban Memorial Hospital

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About Sanjeev Kumar

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 guidelinesHandling of CAPA, Deviation, OOS, Change ControlQuality Risk ManagementTrainer 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.

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Ruban Memorial Hospital
Ruban Memorial Hospital
Rtd - Associate Vice President - QA, Amneal
patna, bihar, india
Employees
12
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11 roles

Sanjeev Kumar work experience

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Associate Vice President - Qa

Amneal India

API Quality Assurance at Site level and R&D level.

Oct 2015 - Nov 2024

Vice President - Quality & Regulatory

Hyderabad Area, India

Vice President - Quality & Regulatory.

May 2014 - Oct 2015

Associate Vice President - Quality

Corporate Quality, Kharghar, Navi Mumbai

A different exposure of work in class. Directly Responsible for two plants at Daman for export to Europe, US and Australian market. and other many plants for domestic markets.Hosted USFDA, KFDA, MHRA, TGA. inspections for Formulation and API. Exposed to Tablets, capsules, Injections for General drugs, Cephalosporines, Beta lactam. Contract manufacturing of products across India.

Jul 2012 - May 2014

Associate Director - Global Quality

Hyderabad Area, India

A great experience to work with a company like Dr. Reddy's Lab Ltd. where System regulates the activity. Heading CQA and External Manufacturing QA, Involved in System harmonization across formulation and API units, Vendor qualification audits (more than 200 plants in India, Europe and China), External Manufacturing Quality with all top most companies in India and Europe and exporting to US, Europe, Russian CIS & ROW market.

Sep 2006 - Jun 2012

Sr. Manager

Aurobindo Pharma

Hyderabad Area, India

Largest Cephalosporins plant for Sterile API, Formulations (Tablets, capsules and Dry powder injections) responsible for Quality Control. Learnt Aseptic operations. experienced a great plant and WOW to plant maintenance.

Sep 2005 - Sep 2006

Sr. Manager - Quality Control, Assurance & Regulatory

Panoli, Ankleshwar

Panoli was the first API plant of Sun Pharma, Hosted first regulatory audits of TGA & USFDA of the plant - without any observations, Were manufacturing Chemical drugs and Steroids for US,Europe, Canada, Australia and ROW. Received first IDMA award for Quality. A great experience to have a fun through team work. Excellent product with excellent quality. Every thing Just in Time and excellent growth years together.

Dec 2001 - Sep 2005

Manager - Quality Control

Verna, Goa. India.

Now the plant is known as Markson. Basic formulation for export of Softgel Capsules, Tablets, Hard gel Capsules. Worked for a little time period only, Allergic to pollen grains in the air, so went back to Gujarat. Alas, I could be survived there !!! A great Company and City too.

May 2001 - Dec 2001

Assistant Manager - Quality

Ratlam, Mp & Kandla, Gujarat, India

Joined as Sr. Executive (QC) at Ratlam Plant, manufacturing API & Formulations (Tablets, Capsules, Oral Liquids and injections), hosted first USFDA inspection of my life in 1997 as QC In-charge. Promoted as AM and posted to EOU plant at Kandla (Gandhidham), Beta Lactam plant for Tablets, Capsules, powder for of, where re-vamping was going on, thereafter hosted MCA (MHRA), MCC, IDA (Netherlands). Unfortunately after Earthquake at Bhuj in 2001, left the company and city, moved to GOA.

Apr 1996 - Apr 2001

Quality Control & Assurance Executive

Bhopal Area, India

My first Job in Pharma, Formulations - Tablets, capsules, Dry powder, Oral Liquid, Parenteral - Dry powder and Liquid injections, Eye drops. Creams, Lotions. Enjoyed working in all area, round the clock. involved in Production, R&D, ARnD, Quality control, Quality assurance, without limitation of boundaries learnt everything. Thanks to ARISTO, to make me versatile.

Nov 1991 - Apr 1996
Team & coworkers

Colleagues at Ruban Memorial Hospital

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3 education records

Sanjeev Kumar education

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, Ist - Class.

Activities and Societies: Approved Analyst from MP and Gujarat, State Drug Authority. for Chemical, Instrumental, Microbiological Analysis.

Ll.B, Law, Member Of Bar Association, Patna

S.K.J. Law College, Bihar University.

Class - X

Mrs. K.M.P.M. High School, Jamshedpur
FAQ

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What company does Sanjeev Kumar work for?

Sanjeev Kumar works for Ruban Memorial Hospital.

What is Sanjeev Kumar's role at Ruban Memorial Hospital?

Sanjeev Kumar is listed as Rtd - Associate Vice President - QA, Amneal at Ruban Memorial Hospital.

Where is Sanjeev Kumar based?

Sanjeev Kumar is based in Bharuch, Gujarat, India while working with Ruban Memorial Hospital.

What companies has Sanjeev Kumar worked for?

Sanjeev Kumar has worked for Ruban Memorial Hospital, Amneal India, Neuland Laboratories Limited, Alkem Laboratories Ltd., and Dr. Reddy'S Laboratories.

Who are Sanjeev Kumar's colleagues at Ruban Memorial Hospital?

Sanjeev Kumar's colleagues at Ruban Memorial Hospital include Manisha Kumari, Archita Sinha, Anil Goswami, Aliza Anthony, and Ranjit Tiwary.

How can I contact Sanjeev Kumar?

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What schools did Sanjeev Kumar attend?

Sanjeev Kumar holds Bachelor Of Pharmacy (B.Pharm.), Pharmacy, Ist - Class. from Lalit Narayan Mithila University.

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