Rajeev Sharma

About Rajeev Sharma

An Alumnus of IIMA & BITS with over two decades of experience in the pharmaceutical industry, including expertise in sterile and OSD dosage forms, I have cultivated a deep understanding of the intricate complexities and nuances involved in adhering to regulatory standards.# Education: • SMP – IIM Ahmedabad • MS – BITS Pilani • Operations Excellence for Leaders – ISB Hyderabad • CLSSBB – KPMG and CLSSGB - Baxter • MBA & B.Pharma • PG Diploma in Regulatory Affairs – Jamia Hamdard • PhD in Management – Lords University, Alwar#Regulatory Framework:Familiarity with Regulations: I\'m well-versed in regulatory requirements, including FDA\'s Current Good Manufacturing Practice (cGMP) guidelines, the EU\'s Annexe 1, and other international standards.# Audit Exposure: USFDA, MHRA, ANVISA, PIC/S, INVIMA, TGA, PIC/S, and other regulatory #Pharma Dosage Form Expertise:Dry powder and liquid injections, lyophilized injections, liposomes, microspheres, suspensions, eye and ear drops, three-piece eye drops, nasals, pre-filled syringes and cartridges, intravenous bags, general, hormones, oncology, antibiotics, monoclonal antibodies (MABs) and Oral solid dosage form.#Operations Excellence:Lean Six Sigma Project: Implemented a project that enhanced the control over the generation and detection of black particles in filled ampoules. This resulted in cost savings of approximately $0.47 million.Prioritising the development of Executive and Operator skills through the LEEP program.Implemented cost-saving measures in Utilities, API, Excipients, Consumables, Spares, and Services. Derived yield improvement initiatives through process optimisations #Training and Development: I\'ve developed and delivered more than 200 training programs for personnel #New Product: Led the company’s operations; secured approvals for 31 ANDA#Collaboration: Worked with PAREXEL, QUANTIC, and HOGAN LOVELLS on 483 response and remediation jobs.Working with Elomatic, a global consulting and engineering partner for the pharmaceutical industry, on the greenfield development of an Oncology facility. collaborated with Spectrum Pharmatech.#Expertise:Lyophilization, Sterile Dosage Formulation, Pharmaceutical Operations, ⁠Commercial Strategy, ⁠Green and Brownfield Projects, ⁠Budgeting, ⁠Process Improvements, ⁠Strategic Partnerships, ⁠6 Sigma, ⁠Regulatory Affairs & Compliance, ⁠Risk Assessment, Equipment Qualification (excluding CSV), CAPA, Investigation, Low Inventory Planning (JIT), FDA/MHRA Response, ⁠LL/TP Site Handling, ⁠Cost-Effective Program, ⁠Training and Mentoring.

Experience

1. Sr General Manager - Operations (General & Onco Injectables and Osd)

   Jodas Expoim Pvt. Ltd

   Sep 2023 — Present · Hyderabad, IN

   Plant Operations with a key leadership role, responsible for overseeing all Projects & operational activities for Russia sitesMoscow (Voskresensk) Unit 1- General injectable - Small and large-volume liquid vials, Prefilled syringes, and lyophilized products. Unit 2, Dry powder lyophilized API and Injectables Moscow (Chertanovo) – Block 1 - Oncology Injectables (Liquid & Lyo. vials, Prefilled syringes & cartridges), and Block 2 - Tablets, Capsules.

Education

• Indian Institute of Management Ahmedabad

  Senior Management Programme, Business, Management, Marketing, and Related Support Services

• Indian School of Business

  Operation Excellence for Leaders

• Jamia Hamdard

  PGDPRA, Regulatory Affairs

• Baxter Academy for Tech & Sciences

  Lean Six Sigma Green Belt

• Lords University

  Doctor of Philosophy - PhD, Management

• Birla Institute of Technology and Science, Pilani

  MS, Manufacturing Management

  2012 — 2014

• Meerut Institute of Engineering and Technology(MIET)

  B.Pharma (Bechelor of Pharmacy), Pharmaceutical Technology

  2000 — 2004

• KPMG

  Lean Six sigma black belt

• Janardan Rai Nagar Rajasthan Vidyapeeth University

  Master of Business Administration - MBA, Pharmaceutical Management