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.

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.

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.

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.
• 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.

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.

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.
• 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 .

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.

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).
• 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)

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.
• 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).

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