Samit Deb Ms, Rac(Us)

Samit Deb Ms, Rac(Us) Email and Phone Number

Strategy | Leadership | Global Operations | Pharmaceuticals @
Samit Deb Ms, Rac(Us)'s Location
United States, United States
Samit Deb Ms, Rac(Us)'s Contact Details

Samit Deb Ms, Rac(Us) personal email

n/a
About Samit Deb Ms, Rac(Us)

Executive management professional having experience in pharmaceutical / biotech / medical device industry. Possess numerous accomplishments which include manufacturing startups, regulatory filings, hosting regulatory inspections, commercializations of generic products and supply chain management. Successfully directed the construction of Parenteral, Softgel, liquid, Solid Orals and Inhalation facilities in the US and India, Strategic planning and Operations.

Samit Deb Ms, Rac(Us)'s Current Company Details
R K Pharma Inc

R K Pharma Inc

Strategy | Leadership | Global Operations | Pharmaceuticals
Samit Deb Ms, Rac(Us) Work Experience Details
  • R K Pharma Inc
    President
    R K Pharma Inc Aug 2022 - Present
  • R K Pharma Inc
    Evp Manufacturing Science Technology(Ms&T) And Global Operations
    R K Pharma Inc Aug 2019 - Aug 2022
    RK Pharma is vertically integrated to manufacture intermediates, API’s, Solid Oral Dosage, Injectables, Sterile Ophthalmics, and New drug deliveries. RK Pharma group of companies include Aktinos Pharma (Intermediates) Apicore (API), Archis Pharma (Marketing &Distribution) 4C Pharma (Pharmacovigilance) and Traminosoft(Software solutions for Healthcare).
  • Jubilant Pharma
    Vp And Head Of Operations North America
    Jubilant Pharma Sep 2017 - Aug 2019
    Yardley, Pennsylvania, Us
    Responsible for North America Operations ( Jubilant Cadista, Jubilant HollisterStier, Jubilant Allergy, Jubilant DraxImage Inc.)
    View
  • Apicore Us Llc
    Vp And Global Head Of Qc/Qa & Ra
    Apicore Us Llc May 2017 - Sep 2017
  • Pii (Pharmaceutics International, Inc.).
    Vice President Operations
    Pii (Pharmaceutics International, Inc.). Aug 2015 - May 2017
    Hunt Valley, Maryland, Us
    View
  • Pii (Pharmaceutics International, Inc.).
    Sr. Director- Manufacturing Operations
    Pii (Pharmaceutics International, Inc.). Apr 2013 - Aug 2015
    Hunt Valley, Maryland, Us
    Primary responsibilities include Manufacturing Operations, Formulation, Validation and Regulatory Affairs. Responsible for the P&L of the Injectable business.Responsible for increasing the footprint for aseptic, solid oral, liquid and aerosols operations by designing new facility, purchasing required instruments, qualification of the area and equipments, recruiting and building new teams, and strategically positioning the company for regulatory approvalPerform Risk assessment for manufacturing products in multi product facility and to maintain uninterrupted supply of drug products to the marketHuman resource administration, training and professional developmentsSuccessful tech transfer of difficult to manufacture productsManagement Representative for Combination productsMonitor the regulatory filing of Pii products and communication with the regulatory bodies. Responsible for pharmacovigilance activities post approval This position reports directly to the President / CEO.
    View
  • Pii (Pharmaceutics International, Inc.).
    Director - Manufacturing Operations
    Pii (Pharmaceutics International, Inc.). Oct 2007 - Apr 2013
    Hunt Valley, Maryland, Us
    Responsible for Manufacturing Operations, Validations, Quality, supply chain and Regulatory Affairs
    View
  • Pii (Pharmaceutics International, Inc.).
    Manager - Qa
    Pii (Pharmaceutics International, Inc.). 2006 - 2007
    Hunt Valley, Maryland, Us
    Develop SOPs, Validation Protocols, responsible for investigation and CAPA, audit API manufacturer and external testing labs, review customer complaints.
    View
  • Pii (Pharmaceutics International, Inc.).
    Associate Director - Qa/Ra
    Pii (Pharmaceutics International, Inc.). 2006 - 2007
    Hunt Valley, Maryland, Us
    Responsible for QA team supporting the manufacturing of solid oral dosage, soft gel, and injectables. Responsible for establishing the RA group and liaison with the FDA for submission of NDA/ANDA/501K applications
    View
  • Biocon
    Manager - Qa
    Biocon 2001 - 2006
    Bangalore, Karnataka, In
    Managed a group of 34 QA professionals. Responsible for auditing clinical sites, hosting regulatory inspections, training of personnel, and monitoring 3rd party contract manufacturer of solid oral dosage and injectables.
    View
  • Cipla Ltd.
    Head - Microbiology Lab
    Cipla Ltd. 1996 - 2001
    Mumbai, Maharashtra, In
    Investigating microbial failures of raw materials and finished products, BET, Sterility, Antibiotic assay, water system validation, area qualification, CCIT,
    View

Samit Deb Ms, Rac(Us) Skills

Regulatory Affairs Validation Pharmaceutics Gmp Regulatory Submissions Glp Biotechnology Quality Assurance Pharmaceutical Industry V&v Quality Control Medical Devices U.s. Food And Drug Administration Technology Transfer Standard Operating Procedure Clinical Trials Microbiology Fda Formulation Oncology Pharmacovigilance Cro Generic Programming Sop Gcp Anda Biopharmaceuticals Quality System Management Verification And Validation Good Laboratory Practice Change Control Drug Development Regulatory Requirements Manufacturing Cro Management Corrective And Preventive Action Market Access Therapeutic Areas 21 Cfr Part 11 Capa Strategy Drug Discovery Project Management Cleaning Validation Good Clinical Practice Generics Cgmp R

Samit Deb Ms, Rac(Us) Education Details

  • Nalsar University
    Nalsar University
    Patent Law
  • Regulatory Affairs Professionals Society
    Regulatory Affairs Professionals Society
    Regulatory Affairs
  • Government Institute Of Science Aurangabad
    Government Institute Of Science Aurangabad
    Microbiology
  • Government College Of Arts And Science Aurangabad
    Government College Of Arts And Science Aurangabad
    Chemistry; Microbiology
  • Kendriya Vidyalaya
    Kendriya Vidyalaya
    General

Frequently Asked Questions about Samit Deb Ms, Rac(Us)

What company does Samit Deb Ms, Rac(Us) work for?

Samit Deb Ms, Rac(Us) works for R K Pharma Inc

What is Samit Deb Ms, Rac(Us)'s role at the current company?

Samit Deb Ms, Rac(Us)'s current role is Strategy | Leadership | Global Operations | Pharmaceuticals.

What is Samit Deb Ms, Rac(Us)'s email address?

Samit Deb Ms, Rac(Us)'s email address is sd****@****int.com

What schools did Samit Deb Ms, Rac(Us) attend?

Samit Deb Ms, Rac(Us) attended Nalsar University, Regulatory Affairs Professionals Society, Government Institute Of Science Aurangabad, Government College Of Arts And Science Aurangabad, Kendriya Vidyalaya.

What skills is Samit Deb Ms, Rac(Us) known for?

Samit Deb Ms, Rac(Us) has skills like Regulatory Affairs, Validation, Pharmaceutics, Gmp, Regulatory Submissions, Glp, Biotechnology, Quality Assurance, Pharmaceutical Industry, V&v, Quality Control, Medical Devices.

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