Amol Sathe

Amol Sathe Email and Phone Number

Project Compliance Manager - GxP | CSV | GDPR | Data integrity | 21 CFR Part 11 | GAMP 5 | EU Annex 11 | IT SOX Controls @ Infosys
bangalore, karnataka, india
Amol Sathe's Location
Pune, Maharashtra, India, India
About Amol Sathe

A Quality-oriented and value-adding professional with 13+ yrs of experience in Pharmaceuticals and IT industry.* Independent Quality Assurance for GxP and Non- GxP IT systems.* Throughout understanding and knowledge of the Life cycle approach, Software development life cycle (SDLC), and Software testing life cycle.* Expertise in Change management, Deviation management on the validated system.* Experience with multiple Regulatory bodies and client audits.* CSV Life cycle management aligned with GAMP5 Methodologies.* Familiar with regulatory requirements and their expectations in relation to Computerized systems. Particularly for 21 CFR Part 11, GAMP5, Annex 11, and ISO/IEC 12207.

Amol Sathe's Current Company Details
Infosys

Infosys

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Project Compliance Manager - GxP | CSV | GDPR | Data integrity | 21 CFR Part 11 | GAMP 5 | EU Annex 11 | IT SOX Controls
bangalore, karnataka, india
Website:
infosys.com
Employees:
217514
Amol Sathe Work Experience Details
  • Infosys
    Senior Consultant
    Infosys Oct 2023 - Present
    India
    Client- Novartis
    View
  • Infosys
    Consultant
    Infosys May 2022 - Present
    India
    View
  • Vita Scientia Globus Pvt Ltd
    Regulatory Compliance Analyst
    Vita Scientia Globus Pvt Ltd Jun 2021 - May 2022
    Pune, Maharashtra, India
    Through VSGPL full time worked for Cognizant on CSV project
    View
  • Omniactive Health Technologies
    Senior Executive
    Omniactive Health Technologies Nov 2019 - Jun 2021
    Ahmednagar, Maharashtra, India
    Quality Assurance (Quality management system and CSV)
    View
  • Syngene International Limited
    Senior Executive
    Syngene International Limited Sep 2017 - Oct 2019
    Bengaluru, Karnataka, India
    Quality Assurance (CSV)
    View
  • M.J. Biopharm Private Limited
    Officer
    M.J. Biopharm Private Limited Apr 2015 - Feb 2017
    Panvel, Maharashtra, India
    Quality Assurance (Equipment Qualification and Validation)
    View
  • Naprod Life Sciences Pvt. Ltd.
    Officer
    Naprod Life Sciences Pvt. Ltd. Apr 2013 - Apr 2014
    CSV & Equipment Validation
    View
  • Midas Care Pharmaceuticals Pvt. Ltd
    Officer
    Midas Care Pharmaceuticals Pvt. Ltd Mar 2012 - Mar 2013
    Quality Management System
    View
  • Neon Laboratories Limited
    Chemist
    Neon Laboratories Limited Aug 2010 - Feb 2012
    Palghar, Maharashtra, India
    Quality Assurance (Equipment Qualification, CSV, and IPQA)
    View

Amol Sathe Education Details

Frequently Asked Questions about Amol Sathe

What company does Amol Sathe work for?

Amol Sathe works for Infosys

What is Amol Sathe's role at the current company?

Amol Sathe's current role is Project Compliance Manager - GxP | CSV | GDPR | Data integrity | 21 CFR Part 11 | GAMP 5 | EU Annex 11 | IT SOX Controls.

What schools did Amol Sathe attend?

Amol Sathe attended Savitribai Phule Pune University.

Who are Amol Sathe's colleagues?

Amol Sathe's colleagues are Arif Undefined, Akash Patil, Aman Sagar, Harika Pachipala, Saurabh Pathare, Hemanth Babloo, Bharathi Nagala.

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