Summary
Overview
Work History
Education
Skills
Personal Information
Work Availability
Languages
Timeline
SoftwareEngineer
Adrian Stanley

Adrian Stanley

Bévilard

Summary

Experienced CSV professional with a strong background in technology-related roles. Proficient in software development, system administration, and technical support. Skilled in problem-solving and optimizing performance. Capable of managing projects and collaborating effectively with teams. Committed to continuous learning and staying current with industry trends to contribute to organizational success.

Overview

26
26
years of professional experience

Work History

CSV QA

Fisher Clinical Services
Lengnau
08.2021 - 05.2024
  • Completed Data Integrity Risk Assessments for QC and Manufacturing Process equipment
  • Network integration and Data Integrity testing of process equipment
  • Developed scripts for data transfers and established security for OPC interfaces
  • Created Risk Register to document and remediate Data Integrity weaknesses
  • Translation and Validation of QC spreadsheets.

CSV Consultant

NNIT
Basel
04.2021 - 06.2021
  • Performed QA oversight development of Workflow app (Batch Review) on Microsoft Power Platform and Platform Qualification.

CSV Consultant

Lonza
Visp
09.2020 - 03.2021
  • Network integration and Data Integrity testing of process equipment
  • Developed and documented process equipment configurations
  • Authored Work Instructions for compliant administration of the systems.

CSV Consultant

Sanofi
Haverhill
10.2019 - 03.2020
  • Assessed Data Integrity Process flows for API Manufacture and Secondary Operations
  • Proposed remediations to issues from receipt of raw materials to manufacturing / packaging process to QC Testing / QA Release.

CSV Consultant

HGP (AG). Switzerland
10.2018 - 10.2019
  • Led the CSV project to migrate all Engineering / R&D applications to new infrastructure for Medical Devices company divestiture.

CSV Consultant

HGP GmbH
03.2017 - 10.2018
  • Remediated validation work for a large Frankfurt-based pharmaceutical company in Regulatory Affairs (RIMS/Submissions Management)
  • QA oversight of Documentum Data Migration Project
  • Tested LIMS (OQ) for second client in Mainz.

CSV Consultant

Porton BioPharma Limited
11.2016 - 03.2017
  • Implemented new QC laboratory systems to FDA Data Integrity expectations
  • Remediated legacy QC laboratory systems to FDA Data Integrity expectations
  • Established disaster recovery procedures for systems.

CSV Consultant

HGP GmbH
04.2016 - 10.2016
  • Remediated validation work for a large Frankfurt-based pharmaceutical company in Regulatory Affairs (RIMS/Submissions Management)
  • QA oversight of Documentum Data Migration Project
  • Tested LIMS (OQ) for second client in Mainz.

CSV Consultant

IBM UK Ltd.
07.2015 - 04.2016
  • Developed security infrastructure qualification documentation for a new datacenter
  • Ensured delivery in accordance with the Master Qualification Plan
  • Returned to role to complete qualified DHCP, Citrix, and network device migration activities.

CSV Consultant

GlaxoSmithKline Ltd.
01.2015 - 07.2015
  • Reviewed and finalized User and System Requirements
  • Collaborated with Business Analysts, Test Manager, and CIO to refine test strategy and schedule
  • QA Oversight for validation of a solution for capture of clinical trial data from Electronic Health Records
  • Developed procedures for the ongoing operation of the system.

CSV Consultant

IBM UK Ltd.
01.2014 - 12.2014
  • Developed security infrastructure qualification documentation for a new datacenter
  • Ensured delivery in accordance with the Master Qualification Plan
  • Returned to role to complete qualified DHCP, Citrix, and network device migration activities.

IGM (Information Governance Management) Manager

Alcon UK Ltd.
08.2013 - 01.2014
  • Implemented Information Governance Management (IGM) for the UK & EMEA Pharma division
  • Developed key IT organization documentation, including Validation Master Plan, Business Continuity Planning, Electronic Change and Documentation Management
  • Developed and provided GxP awareness training
  • Provided PQM support for remediation activities.

IGM (Information Governance Management) Manager

Novartis UK & Ireland Ltd
01.2011 - 01.2013
  • Managed IGM activities for the UK and Ireland Pharma organization
  • Implemented an IGM control framework to replace existing processes
  • Acted as Senior Project Quality Manager (PQM) on local and global projects
  • Interfaced with business users and IT units to ensure physical and electronic data met required controls.

Manager, Security Assessments

GlaxoSmithKline, GSK
01.2010 - 01.2011
  • Managed the Security Assessments process for Information Security Assurance
  • Provided timely and consistent input to both formal (Solutions Design) and informal security architecture consultancy requests
  • Expanded Information Loss Prevention solution ( to include all “Crown Jewels” applications.

Manager - Security Events

GlaxoSmithKline, GSK
01.2007 - 01.2010
  • Arranged deployment of log agents to all critical infrastructure
  • Managed process for simple analysis of log data to identify suspicious behaviours
  • Remediated a 2-star internal audit (serious control deficiencies) during first week in role to 5-star audit (well managed) in follow-up audit.

Principal Support Analyst

GSK
01.2000 - 01.2007
  • Developed automation and data import / export tools for Chromatography Data Systems (CDS)
  • Technical lead for the deployment of 3 Chromatography Data Systems in UK, USA, Canada, and France.

Helpdesk Analyst

Glaxo Wellcome
Stockley Park
01.1998 - 01.2000
  • Answered user inquiries to resolve computer software or hardware operation problems.

Education

6.0 MIT CEUs (Continuing Education Units). - Smart Manufacturing

MIT Professional Education
Massachusetts (Virtual)
02-2021

PGCE – Science (Chemistry) - Chemistry Teacher Education

University of York
York, UK
07-1996

Bachelor of Science - Chemistry

The University of York
York
07-1995

Skills

  • Quality risk management
  • Training and mentoring
  • Test script development
  • Stakeholder Communication
  • Teamwork and Collaboration
  • Professionalism
  • Task Prioritization
  • Critical Thinking
  • Analytical Skills
  • Analytical Thinking
  • Standard Operating Procedures
  • Requirements Gathering
  • Data Integrity Validation
  • Test case development
  • Regulatory Compliance
  • Problem-solving aptitude

Personal Information

Date of Birth: 09-Mar-1970

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Languages

English
Native language
French
Beginner
A1
German
Beginner
A1

Timeline

CSV QA

Fisher Clinical Services
08.2021 - 05.2024

CSV Consultant

NNIT
04.2021 - 06.2021

CSV Consultant

Lonza
09.2020 - 03.2021

CSV Consultant

Sanofi
10.2019 - 03.2020

CSV Consultant

HGP (AG). Switzerland
10.2018 - 10.2019

CSV Consultant

HGP GmbH
03.2017 - 10.2018

CSV Consultant

Porton BioPharma Limited
11.2016 - 03.2017

CSV Consultant

HGP GmbH
04.2016 - 10.2016

CSV Consultant

IBM UK Ltd.
07.2015 - 04.2016

CSV Consultant

GlaxoSmithKline Ltd.
01.2015 - 07.2015

CSV Consultant

IBM UK Ltd.
01.2014 - 12.2014

IGM (Information Governance Management) Manager

Alcon UK Ltd.
08.2013 - 01.2014

IGM (Information Governance Management) Manager

Novartis UK & Ireland Ltd
01.2011 - 01.2013

Manager, Security Assessments

GlaxoSmithKline, GSK
01.2010 - 01.2011

Manager - Security Events

GlaxoSmithKline, GSK
01.2007 - 01.2010

Principal Support Analyst

GSK
01.2000 - 01.2007

Helpdesk Analyst

Glaxo Wellcome
01.1998 - 01.2000

6.0 MIT CEUs (Continuing Education Units). - Smart Manufacturing

MIT Professional Education

PGCE – Science (Chemistry) - Chemistry Teacher Education

University of York

Bachelor of Science - Chemistry

The University of York
Adrian Stanley