Fiona Rutter

Fiona Rutter Email and Phone Number

Quality Systems Manager @ Self-employed
Reading, Reading, United Kingdom
Fiona Rutter's Location
Greater Reading Area, United Kingdom
Fiona Rutter's Contact Details

Fiona Rutter personal email

n/a

Fiona Rutter phone numbers

About Fiona Rutter

My experience in quality management systems, quality assurance, training and procedural document management in a regulated industry spans over 30 years’. I have held positions in both Pharma and CRO organisations with an emphasis in Good Clinical Practice but knowledge of more recently Good Manufacturing and Distribution Practices.I am a collaborative team worker and I love facilitating change and systems implementations. I enjoy seeking out opportunities for coaching and mentoring teams and individuals at all levels within organisations.I have benefited for a career which has always included the need to apply my leadership skills to facilitate and support multi-disciplinary and virtual teams across multiple geographical regions.Do reach out to me if you feel I could add value to your team I would love to help explore how we could work together.

Fiona Rutter's Current Company Details
Self-employed

Self-Employed

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Quality Systems Manager
Reading, Reading, United Kingdom
Fiona Rutter Work Experience Details
  • Self-Employed
    Quality Systems Manager
    Self-Employed
    Reading, Reading, United Kingdom
  • Synairgen Research Ltd
    Quality Systems Manager
    Synairgen Research Ltd Mar 2022 - Present
  • Indivior
    Quality Systems And Opex Manager
    Indivior Jul 2020 - Mar 2022
    Slough, England, United Kingdom
  • Indivior
    Senior Global Quality Systems Specialist
    Indivior Dec 2017 - Jul 2020
    Slough, Berkshire, United Kingdom
  • Shire Pharmaceuticals
    Associate Director Quality Operations Support Lead
    Shire Pharmaceuticals Mar 2014 - Aug 2017
    Basingstoke
    I am responsible for providing Quality Operations leadership for the successful implementation of quality systems, compliance initiatives and inspection activities. Practically on a daily basis I perform QMS technology system administration and have the opportunity to implement process improvements within R&D QA & Compliance for QMS systems as well as R&D in GCP environments.Systems I work or have worked with with include MasterControl, Mastercontrol QAAD, Saba, Veeva Quality Docs, Qumas, Trackwise, Servicenow, Jira, Sharepoint.I have been involved in integration and harmonisation actives facilitating mulitifunctional workgroups to define or improve processes, translating improvements into procedural documentation, facilitating the revision / development and quality review of procedural document content, training identification, and inspection readiness activities.
  • Shire Pharmaceuticals
    Senior R&D Compliance And Process Associate (Learning And Quality Management Systems Administration)
    Shire Pharmaceuticals Jan 2013 - Mar 2014
    United Kingdom
    Manage the administration of R&D Systems as part of the Quality Assurance and Compliance team. Systems include: MasterControl Document Management System (Lead System Administrator) Saba - Learning Management System MasterControl QAADManagement of end user training and support through development and delivery of training and proactively responding to queries regarding use of applications and laptop configuration. Routine administration activities for systemsSupport for cross-divisional projects to advance the administration of training and quality management systems including process improvement, system implementation, user acceptance testing.
  • Self Employed
    Quailty Management And Training Consultant
    Self Employed Mar 2011 - Jan 2013
    • Development and evaluation of company quality management systems including policies and procedures and training programmes• Audit and Inspection preparation and support
  • Paragon Biomedical
    Director, Global Training And Development
    Paragon Biomedical Sep 2008 - Mar 2011
    Development, management, and evaluation of Global Enterprise Wide Learning and Development. Interactions with sponsors in relation to Quality Management Systems and Learning and Development.
  • Paragon Biomedical (Now Clinipace Worldwide)
    Manager, Quality Management Systems
    Paragon Biomedical (Now Clinipace Worldwide) Sep 2003 - Oct 2008
    Development, management, and evaluation of Quality Management Systems, (Training, Procedures and Quality Control Systems. Strategic interactions with sponsors in relation to Quality Management Systems.
  • Clintrials Research Ltd.
    Director, Training - Clinical Operations
    Clintrials Research Ltd. May 1997 - Apr 2001
    • Managed and delivered training for Clinical Operations (Europe and Asia Pacific), including approximately 300 staff in data management, biostatistics and clinical monitoring. Coordinated company training brochure and associated training courses.• Facilitated and actively participated in quality management activities for Clinical Operations including; process improvement, procedural development and maintenance. • Performed audits of the quality assurance department as part of the master audit plan. • Provided strategic input into the development of data management audit plans and quality assurance training plans. • Coordinated client audits and regulatory agency inspection support on behalf of Clinical Operations including preparation for and participation in a voluntary MCA (now MHRA) inspection.
  • Wyeth Research
    Clinical Data Coordinator (Quality)
    Wyeth Research May 1991 - May 1997
    Data Management, Quality Control and Training

Fiona Rutter Skills

Quality Management Master Control Quality System Sop Gcp Training Process Improvement Management Clinical Trials Employee Training Pharmaceutical Industry Cro Clinical Research Ctms 21 Cfr Part 11 Data Management Clinical Development Change Management Software Documentation Microsoft Office Standard Operating Procedure Good Clinical Practice Policy Regulatory Compliance Personal Development Training Leadership Cro Management Business Process Improvement Pharmaceuticals Process Clinical Trial Management System Quality Systems Documentation Problem Solving Clinical Quality Improvement Personnel Development

Fiona Rutter Education Details

Frequently Asked Questions about Fiona Rutter

What company does Fiona Rutter work for?

Fiona Rutter works for Self-Employed

What is Fiona Rutter's role at the current company?

Fiona Rutter's current role is Quality Systems Manager.

What is Fiona Rutter's email address?

Fiona Rutter's email address is fr****@****net.com

What is Fiona Rutter's direct phone number?

Fiona Rutter's direct phone number is +178148*****

What schools did Fiona Rutter attend?

Fiona Rutter attended University Of Warwick, University Of West London.

What skills is Fiona Rutter known for?

Fiona Rutter has skills like Quality Management, Master Control, Quality System, Sop, Gcp, Training, Process Improvement, Management, Clinical Trials, Employee Training, Pharmaceutical Industry, Cro.

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