Quality Assurance Manager
- About
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- Email Address
- g.cooper@abdn.ac.uk
- Telephone Number
- +44 (0)1224 438654
- Office Address
- School/Department
- School of Medicine, Medical Sciences and Nutrition
Biography
Quality Manager for ISO 9001:2018-certificated Rowett Research Institute and Information Security Manager for ISO 27001:2013-certificated Grampian Data Safe Haven (DaSH).
Former member of the Chartered Quality Institute & Chartered Quality Professional (MCQI CQP) and a former IRCA Registered Lead Auditor with extensive supplier and service provider auditing experience for both the Pharmaceutical and Medical Device sectors. (Previous experience of auditing to 21 CFR parts 820, ISO13485, ISO 9001, PS9000, PS9001 and cGMP requirements as well as company-specific technical agreements).
Experienced quality assurance professional with sound background in GMP compliance requirements for both the Pharmaceutical and Medical Device industries, comprehensive knowledge of GCP/Research Governance requirements for human intervention studies and an active interest in all process-based and risk-based ISO quality management systems, risk management and the research data management lifecycle, including use of electronic laboratory notebook software.
Qualifications
- BSc (Hons) Biochemistry1989 - University of London
Memberships and Affiliations
- Internal Memberships
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Deputy Chair, Lay Member and mentor - Rowett Ethics Panel
Deputy Chair, Rowett Human Studies Management Committee
Various UoA and NHSG compliance-based working groups eg. MHRA inspection readiness, NHS Grampian biorepository HTA accreditation, North Node Privacy Advisory Committee (NNPAC) working group, Grampian Data Safe Haven (DaSH) Scottish Government accreditation and ISO27001 certification projects, PET centre GMP compliance project
- External Memberships
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Former Honorary Named GCP Archivist for NHS Grampian (Nov 2012 - Dec 2015)
Former Chair, Alternate Vice-Chair and Lay Plus member - NRES Ethics Committees - North of Scotland 2 (May 2011 - May 2016)
- Teaching
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Non-course Teaching Responsibilities
Rowett Institute Copyright compliance officer - Human Nutrition and Clinical Nutrition MSc programmes (2016 - 2021)
Adviser - Professional Practice "QA in a Laboratory Environment" - Human Nutrition and Clinical Nutrition MSc programmes (2016 - 2017)
`Chair` for Ethics Role Play sessions for Fundamentals of Research Design (2017 - 2022).