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

Hyderabad, In

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.

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

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

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

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

Nalagarh, Himachal Pradesh, India

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

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

Baddi

Dehradun, Uttarakhand, India

Haridwar, Uttarakhand, India

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________________________________________

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

Meerut, Uttar Pradesh, India

Senior Management Programme

MODULES:- • Marketing • Finance Management • Financial markets and Risk • Operations & Supply Management • Organizational behavior • Human.

Doctor Of Philosophy, Management

ANALYZING STRATEGIC MANAGEMENT PRACTICES IN THE INDIAN PHARMACEUTICAL INDUSTRY: A CASE STUDY OF A LEADING PHARMACEUTICAL COMPANY

Ms, Manufacturing Management

Course Title:- 1) Manufacturing Orgn. & Management 2) TQM 3) Product Design 4) TPS 5) Marketing 6) SCM 7) PM 8) Strategic management &.

Exercising Leadership

Discover a diagnostic-and-action process for exercising leadership that explores the following foundational principles and strategies: 1).

Master Of Business Administration - Mba, Pharmaceutical Marketing And Management

Pharmacetical Management

Pgdpra (Post Graduate Diploma In Pharmaceutical Regulatory Affairs)

Having The Highest Marks in "International Licensing"

Lean Six Sigma Green Belt, Dmaic, Lean, Tps

Patent Cooperation Treaty (Pct)

Patent Cooperation Treaty (PCT) provides an overview of this international treaty administered by the World Intellectual Property.

B.Pharma (Bechelor Of Pharmacy), Pharmacy, First Devision