Mike Roberts Email
Director of Business Systems @ TMC Pharma Services Ltd
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Mike Roberts Location
- Bude, GB
Mike Roberts Work
- Director of Business Systems @ (January 2026 - Present)
- Safety Systems and Validation Project Manager @ (June 2025 - December 2025)
- Senior Manager, R and D Quality @ (July 2023 - December 2024)
- PV Systems and Validation and CSV Consultant, Director @ (February 2009 - June 2023)
- QA Consultant @ (February 2023 - May 2023)
- Associate Director, Safety Systems @ (December 2022 - February 2023)
- Project Manager @ (May 2022 - December 2022)
- PV Systems Principal Specialist @ (February 2022 - April 2022)
- Argus Safety Consultant @ (October 2021 - January 2022)
- Interim Managing Director @ (April 2021 - June 2021)
- Argus Safety Validation Consultant @ (March 2019 - March 2021)
- PV IT Specialist @ (February 2019 - March 2019)
- PV Systems Consultant @ (February 2018 - February 2019)
- Argus Safety consultant @ (January 2017 - February 2018)
- Director, IT Drug Safety Systems @ (July 2016 - December 2016)
- Argus Safety Validation Consultant @ (July 2015 - June 2016)
- PV Systems Consultant @ (December 2013 - July 2015)
- Testing, Quality and Validation Business Lead - OASIS programme @ (November 2011 - December 2013)
- Drug Safety systems consultant @ (March 2007 - October 2011)
- Solution Architect @ Novartis (October 2004 - February 2006)
- Drug Safety Systems consultant @ Assured Information Systems (April 2002 - October 2004)
- Argus Safety consultant @ Actelion (June 2002 - August 2004)
- Argus Safety consultant @ Relsys International (March 2000 - June 2004)
- Argus Safety consultant @ Helsinn (January 2003 - January 2004)
- Safety systems developer and DBA @ Glaxo Wellcome (April 1998 - March 2000)
- Drug Safety systems consultant @ Glaxo Wellcome (January 1995 - November 1997)
- Oracle consultant @ (September 1994 - January 1995)
- Software Engineer @ Praxis Systems (August 1991 - September 1994)
Mike Roberts Education
- Polytechnic of Wales
1st Class (Computer Studies)
1987-1991 - The Rawlett School 1980-1987
Mike Roberts Skills
- Computer System Validation
- 21 CFR Part 11
- GxP
- Validation
- Pharmacovigilance
- SDLC
- Requirements Analysis
- Oracle
- Business Analysis
- Drug Safety
- Argus Safety
- Quality Assurance
- Testing
- Change Control
- PL/SQL
- Informatics
- ICH-GCP
- Clinical Development
- GCP
- Lifesciences
- CRO
- Clinical Data Management
- Clinical Trials
- Data Management
- EDC
- Regulatory Submissions
- Sop
- Regulatory Requirements
- Regulatory Affairs
- Pharmaceutical Industry
- FDA
- SQL
- User Acceptance Testing
- Data Migration
- Life Sciences
- Test Management
- U.S. Title 21 CFR Part 11 Regulation
- Consulting
- Ich Gcp
- Sales
- Strategic Planning
- Support
- Ich
Mike Roberts Summary
- Mike Roberts, based in Bude, GB, is currently a Director of Business Systems at TMC Pharma Services Ltd. Mike Roberts brings experience from previous roles at TMC Pharma Services Ltd, Moderna, Pink Octopus Consulting and Truliant Consulting. Mike Roberts holds a 1987 - 1991 1st Class in Computer Studies @ Polytechnic of Wales. With a robust skill set that includes Computer System Validation, 21 CFR Part 11, GxP, Validation, Pharmacovigilance and more. Mike Roberts has 1 emails on RocketReach.
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Top TMC Pharma Services Ltd Employees
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Victoria Datsenko
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Alison Shaw
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