Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct,

Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct, Email and Phone Number

Sr. General Manager - Operations (General and Onco Injectables and OSD ) @ Jodas Expoim Pvt. Ltd.
Hyderabad, IN
Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct,'s Location
Hyderabad, Telangana, India, India
About Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct,

As an alumnus of the Birla Institute of Technology & Science (Pilani) and Indian Institute of Management (Ahmedabad), I hold a result-driven leadership position with over 20 years of experience in the pharmaceutical manufacturing industry. I have led organizations with annual revenues exceeding 5 billion rupees. My extensive managerial & leadership experience spans over a decade.With a strong leadership capability, negotiation skills, & analytical ability, I aspire to become a visionary leader in global pharmaceutical operations.Notable achievements include:- **Project Management:** Successfully leading a project valued at $77.68 million.- **Regulatory Compliance:** Obtaining approvals from the USFDA, UKMHRA, ANVISA, and PIC/S on the first attempt.- **Training and Development:** Conducting over 200 training sessions on data integrity, aseptic behavior, and quality culture enhancement.- **Quality Assurance:** Leading the company’s operations & securing approvals for 20 ANDA products.- **Collaboration:** Working with PAREXEL, QUANTIC, and HOGAN LOVELLS on 483 response and remediation activities.- **Lean Six Sigma Project:** Implementing a Lean Six Sigma project to reduce and generate black particles in filled units, resulting in cost savings of approximately $0.47 million.My expertise encompasses the production of sterile dosage forms, including ampoules, vials, PFS, cartridges, DPI, MABs, and lyophilized injections. Additionally, I have experience in nasal drops, eye and ear drops (in three pieces and BFS), and tablets and capsules.Currently, I hold the position of Senior General Manager of Operations (Site Head) at Jodas Expoim Pvt. Ltd., overseeing the day-to-day operations of two sites in Russia: Voskresensk - General InjectablesChertanovo - Oncology OSD and InjectablesFor the past ten years, I have spearheaded the management of various departments within the plant, including Dr. Reddy’s Lab (FTO 6), Akorn India (Hormone Block), and Immacule Lifesciences).Previously, I served as General Manager - Production and Project Management, overseeing the Mfg., Pkg. WH , and small-scale facility operations for three liquid lines containing three Lyophilizers, employing approximately 200 individuals. I have successfully navigated audits conducted by various regulatory bodies, including:- USFDA: Auditors: Mr. Peter Baker, Ms. Parul Patel, Mr. Thomas Arista, & Mr. Masood Motamed- MHRA: Auditors: Ms. Martine Powell & Mr. Alan Moon- ANVISA: Auditors: Mr. Eduardo Hurtado & Mr. Renato Hurtado- TGA: Auditors: Mr. Carl Kelly & Mr. Greg Orders

Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct,'s Current Company Details
Jodas Expoim Pvt. Ltd.

Jodas Expoim Pvt. Ltd.

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Sr. General Manager - Operations (General and Onco Injectables and OSD )
Hyderabad, IN
Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct, Work Experience Details
  • Jodas Expoim Pvt. Ltd.
    Sr. General Manager - Operations (General And Onco Injectables And Osd )
    Jodas Expoim Pvt. Ltd.
    Hyderabad, In
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  • Jodas Expoim Pvt. Ltd.
    Senior General Manager (Site Head) - Operations (General & Onco Injectables And Osd, Russia)
    Jodas Expoim Pvt. Ltd. Sep 2023 - Present
    Hyderabad, Telangana, India
    Site Head - Plant Operations with a key leadership role, responsible for overseeing all Projects & operational activities for Russia sites Moscow (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.
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  • Jodas Expoim Pvt Ltd
    General Manager -Operations (General & Oncology - Osd And Injectables At Russia & Belarus)
    Jodas Expoim Pvt Ltd May 2021 - Sep 2023
    Hyderabad, Telangana, India
    Responsible for 3 Green and Brownfield project sites, New-age Global, a state-of-the-art manufacturing facility with complete isolation technology, delivers highly complex and technologically challenging formulations.Plant Operations Head with a key leadership role, responsible for overseeing all Projects & operational activities for Russia and Belarus project. Responsible for three sites, two in Russia, Voskresensk (General Injectables, API (3 units), Cardiac stents, and Catheters), Chertanovo (oncology OSD and Injectables), and one in Minsk, Belarus (General OSD) Voskresensk General injectable - Small and large-volume liquid vials, Prefilled syringes, and Lyophilized products.APIs - 3 suits of APIs - General, Onco and Low weight heparin APIs. Cardiac Stents and Catheters  Moscow - Oncology facility – Oncology OSD (Tablets & Capsules) and Oncology Injectables (liquid & Lyo. vials, Prefilled syringes & cartridges)  Belarus – General OSD Facility - Tablets and Capsules
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  • Immacule Lifesciences
    General Manager- Production & Project Management
    Immacule Lifesciences Aug 2019 - May 2021
    Nalagarh, Himachal Pradesh, India
    GM- Production & Project Management – Leading an approved sterile facility by USFDA, MHRA, ANVISA, PIC/S, INVIMA, TGA etc. Responsible for manufacturing, packing, warehouse and small-scale facility with three lines for liquid and Lyophilized products. Responsible for program management for US and Europe. Responsible for successful ANDA submission, approval and also supply to US and Europe.Reporting to: Managing Director Team Size: 183
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  • Baxter International Inc.
    Dy. General Manager - Cqa / Projects
    Baxter International Inc. Jul 2017 - Aug 2019
    Ahmedabad, Gujarat, India
    Worked with various projects related to Sterile dosage and Quality, Previously leading as DGM- CQAResponsible for QMS, Self-inspection, Assessment of Quality alerts and Global quality regulatory intelligence, Management of audits & compliance, review of the Investigation, ensure the CAPA implementation• Delivering successful organizational change management, people leadership, and operational excellence • Command on documentation & validation aspects, review of validation Manufacturing, Packing, Warehouses documents.• Work for future enhancement for the system and facilities as per regulatory requirements • To verify that the current executions are done in correct and timely manner; further to review that whether this execution is adequate enough and in line with the current regulatory requirement and expectations.• To perform internal quality audits in order to ensure the compliance to all systems and procedures and ultimately building the quality culture.• To impart training to personnel regarding enhancement in regulatory guidelines, systems and processes.• To review the investigation for OOS, deviation, OOT for its sufficiency and root cause identification and to provide guidance and to get updates in coordination with plant/CQA QMS frame.• To ensure observation cited during audit by internal or external agencies are timely and efficiently closed in coordination with relevant function form.• To perform the audit for verification of compliance level of all plants.#Data Gemba for verification of data integrity as per ALCOA++* Performed the audits at loan license sitesAudit Faced- QP- Poland, NDA- Uganda, GCC- Saudi Arabia, MCC- South Africa, INVIMA, TFDA-Tanzania, South Korea, Russia, MOH Turkey, TGA- Australia, MalawiReporting - SVP - CQA, Head Engineering & Projects
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  • Immacule Lifesciences
    Head (Agm) Production
    Immacule Lifesciences Oct 2014 - Jun 2017
    Nalagarh - Baddi (Himachal Pradesh)
    • Heading the Manufacturing, Packing & Warehouse & Small Scale facility at Immacule Lifesciences Pvt Ltd (Approved by MHRA, ANVISA,INVIMA, PIC/S Ukraine )• Managing and handling the Lyophilized product and Liquid ampoule for ROW Market • Managing work force independently with respect to work allocation, productivity• To perform the gap assessment of manufacturing operations to identify the compliance issues• To develop the corrective and preventive action plans - Implementation of the actions identified to mitigate the gaps• To perform the risk assessments for multi product facilities to determine the risks associated with cross contamination and mitigation of the identified gaps.• To create procedures and records for the manufacturing operations• To perform risk assessment related to quality of incoming materials, process validation.• Knowledge on product life cycle – material receipt to distribution• To establish the production, process and packing controls through procedures implementation• To create plans and execution for automation activities• To support the manufacturing investigation to determine the root cause and CAPA• To support site team to write investigations through technical expertise• Ongoing verification of manufacturing operations to ensure that they were performed as it is defined• To train manufacturing personnel on – material dispensing, Sampling, in-process checks, batch records review, packaging operations, manufacturing activities, equipment operations• Preparation remediation status update based on the progress of actions and notification to management Development of interim controls for the long lead action items to ensure compliance by avoiding the possible risk.Regulatory Approval - INVIMA - Columbia , Philippines , QP Audit - MHRA, Nigeria (NAFDAC) , PIC/S Ukraine, UK MHRA etc Reporting to: Managing Director Team Size: 150
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  • Immacule Lifesciences
    Sr. Manager - Production
    Immacule Lifesciences Oct 2014 - Oct 2015
    Nalagarh, Himachal Pradesh, India
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  • Akorn, Inc
    Head (Manager) Production
    Akorn, Inc 2013 - 2014
    Paonta Sahib , Sirmour ,Himachal Pradesh
    Managing and handling Production and Packing of Hormone Block with more than 80 team member with 6 Exhibit batch ~ Managing work force independently with respect to work allocation, productivity execution, line balancing, shift management, Improvement project etc ~ Ensuring the Investigation & Disposition of incident in Dept ~ Active Lead member of Project team for new expansion Heading the production activities in Hormone Injectable and implementation of USFDA & cGMP requirements and maintenance of Regulatory and Quality system. • Meeting Quality and Safety Standards, Ensuring compliance with respect to Quality Assurance. • Core Member of Site Leadership team for project, Quality and Productivity. * Successfully facing the mock audit for USFDA by Ex- Inspectors of USFDA (PAREXEL Consulting) * Successfully facing the audit for USFDA  Trained on QMS, Investigations, HVAC, water system and good documentation practices by USFDA experts Mr. Mark Balboni and Mr. Jack Goodson Ex- FDA auditor (Paraxel Consultants) from 19th to 20th April 2014.  Trained on Aseptic Technique by Dr. Sumant Baukhandi – GMP Pharma Institute
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  • Dr. Reddy'S Laboratories
    Head - Injectable Department ( Lyophilized Dosage Form)
    Dr. Reddy'S Laboratories 2011 - 2013
    Formulation Techops Unit Vi (Baddi - Solan Himachal Pardesh)
    Managing and handling Over all Section of Production and Packing of Lyophilized Injectable product Managing the production activities in Injectable and implementation of cGMP requirements and maintenance of quality system Responsible for Planning, Operations, Ensuring the material availability, Viable Vision, Audits and InspectionPlanning and managing the activities related to injection (Autoclave, Tunnel, Vial Washing, Filling, Sealing Machine , Lyophilizer, Packing to dispatch and Media Fill etc)Reviewing the Qualification Protocol, General & Operation SOP, Annexure Format and all Related cGMP documentationHandling of deviation, change controls, CAPA and risk analysis, failure investigation,market complaint related to ProductionPreparing and repairing documents for audits governed by many international and domestic bodies and resolving the queriesManaging work force independently with respect to work allocation, productivity execution, line balancing, shift management, motivating staffMeeting Quality and Safety Standards. Ensuring compliance with respect to Quality Assurance and EHS requirementsResponsible for Safety Audit and Compliances as per ScheduleResponses for Safety Audit and compliance for Injectable and Ointment deptCoordinating with departments like Stores, QA, Engineering, Planning, Purchase and other support functions in order to achieve, sustain and improve productivityIdentification of training needs and imparting it to increasing the productivityStrictly observed the cGMP in the deptTo ensure the Investigation & Disposition of incident in DeptBudgeting and expense control, procurement of Assets, Purchase requisition for instruments and their accessoriesInitiatives and implementation of various Cost Improvement plans (CIP)Member of cross functional audit team and conducted various audits across the formulations units
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  • Dr. Reddy'S Laboratories
    Assistant Manager- Production
    Dr. Reddy'S Laboratories 2010 - 2011
    Baddi
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  • Rusan Pharma Ltd
    Sr. Executive Qa - Osd And Injectables
    Rusan Pharma Ltd 2009 - 2010
    Dehradun, Uttarakhand, India
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  • Themis Medicare Limited
    Sr. Executive - Production
    Themis Medicare Limited 2007 - 2009
    Haridwar, Uttarakhand, India
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  • Cipla
    Management Staff
    Cipla Jun 2007 - Oct 2007
    Goa
    Cipla Ltd. (Caring for Life ) is Approved by US FDA, UK MHRA,MCC (S.A), TGA (AUSTRALIA), WHO cGMP, MOH (TANZANIA, LIBYA) PIC (EUROPE, GERMANY) IDA, MSF (BELGIUM), WHO, TDP (CANADA), ANVISA (BRAZIL), UNICEF (GENEVA), NIP (HUNGARY) etc CIPLA Export 175 Countries all in worldManagement Staff –Quality Assurance• Preparation of URS, comparison of Machines.• Project related documentation and work• The function related to Injectable as well as Form Fill & Seal (FFS) Dept• The function related to Manufacturing of Solution and Suspension. With all documentation• Designed and worked with the best manufacturing process and facility as specified by US FDA,UK MHRA, TGA & MCC (South Africa)• Validation of Steam Sterilizer, DHS and Qualification of Area• Qualification of manufacturing tank inbuilt with Magnetic Stirrer• OPERATION & VALIDATION procedure for Steam Sterilization in-placeTraining & Seminar • Media Fill, Good Documentation Practices, cGMP, CAPA, Environmental Monitoring,FMEA etcReporting to: Project Head Team Size: 35________________________________________
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  • Sun Pharma
    Officer -Production
    Sun Pharma Mar 2006 - May 2007
    Halol, Gujarat, India
    Sun Pharma (Halol) Injectable plant is approved by US FDA , UK MHRA, MCC (S.A), ANVISA (BRAZIL), INVIMA (COLUMBIA), WHO cGMP, MOH (TANZANIA, UKRAINE) etc. It has manufacturing the dosage Forms, Sterile powder injections, Small volume injections, Suspension, Emulsion, liquid, Lyophilized & Pre filled syringe the ELY LILLY productOfficer - Production • Knowledge About the function related to Injectable as well as Eye Drop• Designed and worked with the best manufacturing process and facility as specified by US FDA, UK MHRA and other Regulatory body• Setup installation and qualification of the machines and Equipments• Preparation and Reviewing the BMR, BPR, MFC & cGMP Documentation• OPERATION & VALIDATION procedure for DHS (Metal Chem.) and Depyrogenation Tunnel (Petals), Steam Sterilization (Pharma Lab & Machine Fabric) Steam Sterilization In-Place Unit, Vial and Ampoule Washing Machine (Petals), Vial and Ampoule Filling & Sealing Machine (Petals)• Knowledge about Lyophilizers (BOC EDWARD, LYBOLD HERACES GmBH)• Knowledge about VALIDATION procedure for HVAC system• VALIDATION of Aseptic Processing For Liquid, Dry Powder and Lyophilized Product.• Preparation of URS, Validation and Qualification protocolAudit Facing• Facing the audit of US FDA, UKMHRA, MCC (S.A), ELY LILLY, ISO & WHO GMP and UKRAINE etcTraining & Seminar• Media Fill, cGMP, Good Documentation Practices , Incidence & Investigation report Role of Microbiology, ANDA, Validation of Filter, Water System. Handling Market ComplainsReporting to: Production ManagerTeam Size: 26
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  • Win Medicare Private Limited
    Assistant Officer - Production (Injectables & Osd)
    Win Medicare Private Limited Dec 2004 - Mar 2006
    Meerut, Uttar Pradesh, India
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Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct, Education Details

Frequently Asked Questions about Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct,

What company does Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct, work for?

Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct, works for Jodas Expoim Pvt. Ltd.

What is Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct,'s role at the current company?

Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct,'s current role is Sr. General Manager - Operations (General and Onco Injectables and OSD ).

What schools did Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct, attend?

Rajeev Sharma (Ph.D.) Smp-Iima, Ms - Bits, Mba B.Pharma, Cssgb, Pgdpra, Pct, attended Indian Institute Of Management Ahmedabad, Lords University, Alwar, Birla Institute Of Technology And Science, Pilani, Harvardx, Janardan Rai Nagar Rajasthan Vidyapeeth University, Jamia Hamdard, Baxter Academy For Tech & Sciences, Wipo, Meerut Institute Of Engineering And Technology(Miet).

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