Rakesh Kumar

Rakesh Kumar Email and Phone Number

Lead Auditor Qualifyze GmbH; Independent cGMP Consultant; ISO 9001:2015 CQI IRCA Auditor @ Invigorate Biotechnologies
Rakesh Kumar's Location
Chandigarh, Chandigarh, India, India
Rakesh Kumar's Contact Details

Rakesh Kumar personal email

About Rakesh Kumar

I am a professional into Bio-pharmaceutical/Pharmaceutical industry in Manufacturing and QMS functions. Precisely, I have around 17 years of industrial experience and accomplished various projects with the organizations.I worked related to commissioning and qualification of Sterile Biopharmaceutical manufacturing facilities (5 Vaccine Manufacturing Facility Projects) and also worked related to setting-up of QMS and have good exposure to regulatory audits viz. USFDA, EDQM, ANVISA, & World Health Organization, Geneva. Besides this I too have strong knowledge in Production of vaccines viz. Hepatitis B, Hib (PRP)-TTBeyond all, determination, competence and self-motivation have inspired me all through my professional carrier. Initiatives, sense of responsibility, ability to plan and organize work, ability to analyze and evaluate technical issues, ability to communicate and effective working relationship with people of diverse national and cultural backgrounds are my plus points.

Rakesh Kumar's Current Company Details
Invigorate Biotechnologies

Invigorate Biotechnologies

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Lead Auditor Qualifyze GmbH; Independent cGMP Consultant; ISO 9001:2015 CQI IRCA Auditor
Rakesh Kumar Work Experience Details
  • Invigorate Biotechnologies
    Quality Consultant
    Invigorate Biotechnologies Oct 2023 - Present
    India
    Biotechnology Research, cGMP Consultancy for Pharmaceutical & Biopharmaceutical Products
  • Qualifyze
    Cgmp Independent Consultant & Eu Gmp Lead Auditor
    Qualifyze Feb 2018 - Present
    India
  • Sun Pharma
    Sr. Manager Ii Corporate Quality Project Management
    Sun Pharma May 2017 - Jan 2018
  • Nectar Lifesciences Limited
    Asstt. General Manager, Quality/Manufacturing Excellence
    Nectar Lifesciences Limited Apr 2016 - 2017
    Mohali
    Manufacturing Facility: Sterile API (Pharmaceuticals Cephalosporins)Validation/Calibration of Equipment, Systems and FacilitiesHandling of Change Control, Deviations, Market Complaints, OOS and other QMS Procedures.Handling a team of more than 30 people.Reporting to General Manager
  • Nectar Lifesciences Limited
    Sr. Manager, Qa
    Nectar Lifesciences Limited May 2013 - 2016
    Punjab, India
    Manufacturing Facility: Sterile API (Pharmaceuticals Cephalosporins)Validation/Calibration of Equipment, Systems and FacilitiesHandling of Change Control, Deviations, Market Complaints, OOS and other QMS Procedures.Handling a team of more than 30 people.
  • Biobridge Healthcare Solutions Pvt Ltd
    Quality & Compliance Specialist
    Biobridge Healthcare Solutions Pvt Ltd Jun 2012 - May 2013
    Chandigarh Area, India
    Conducting GMP & QMS AuditsProvide Consultancy to Pharmaceutical & Biopharmaceutical IndustryConduct GMP Trainings and Workshops
  • Panacea Biotec Ltd.
    Sr. Manager,Qa
    Panacea Biotec Ltd. Apr 2009 - Jan 2012
    Validation of Equipment, Systems and FacilityCalibration ManagementChange ControlRisk AnalysisDeviation, OOS and CAPAProduct Batch ReleaseGMP Documentation ControlGMP Staff TrainingEnvironment Monitoring of Critical Utilities and Cleanrooms
  • Panacea Biotec Ltd
    Deputy Manager Qa
    Panacea Biotec Ltd Sep 2001 - Mar 2009
    Prodction of ARM Bulk of Rec. Hepatitis BProduction of ARM bulk of Hib-TT ConjugateManaging Production of Critical UtilitiesManaging Cleanroom Classification Status

Rakesh Kumar Skills

Pharmaceutical Industry Pharmaceutical Sales Claim Team Management Negotiation Quality Management Logistics Management Customer Service Regulatory Affairs Sales Operations Validation Market Planning V&v Technology Transfer Quality Auditing Sop Certified Associate Trainer By International Board Of Certified Trainers Cleaning Validation Gmp Vaccines Capa Biopharmaceuticals Quality Assurance Deviations Pharmaceutics Microbiology Change Control Aseptic Processing Fda Sterilization Gxp 21 Cfr Part 11 Quality System Cgmp Training Project Management Regulatory Requirements Glp Computer System Validation Calibration Lims Regulatory Submissions Trackwise Gamp Mhra Dissolution Deviation Management Equipment Qualification Hplc Fda Gmp Batch Release Cgmp Practices Anda Sop Development Chromatography Formulation Oos Cgmp Manufacturing Uv Usp

Rakesh Kumar Education Details

Frequently Asked Questions about Rakesh Kumar

What company does Rakesh Kumar work for?

Rakesh Kumar works for Invigorate Biotechnologies

What is Rakesh Kumar's role at the current company?

Rakesh Kumar's current role is Lead Auditor Qualifyze GmbH; Independent cGMP Consultant; ISO 9001:2015 CQI IRCA Auditor.

What is Rakesh Kumar's email address?

Rakesh Kumar's email address is ra****@****ail.com

What schools did Rakesh Kumar attend?

Rakesh Kumar attended Panjab University, Panjab University.

What are some of Rakesh Kumar's interests?

Rakesh Kumar has interest in Science And Technology, Education.

What skills is Rakesh Kumar known for?

Rakesh Kumar has skills like Pharmaceutical Industry, Pharmaceutical Sales, Claim, Team Management, Negotiation, Quality Management, Logistics Management, Customer Service, Regulatory Affairs, Sales Operations, Validation, Market Planning.

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