Andrew Norrish Email & Phone Number

Plymouth, GB

• Management Representative for the Pall-Newquay site, member of the site leadership team and accountable for the maintenance and development of the site’s Quality Management System to ISO 9001, ISO 13485 and FDA 21 CFR.
• Hosting Notified Body, Regulatory (F.D.A.) and Corporate (Danaher) audits as Management Representative for the Pall-Newquay site.
• Driving quality through a Quality Action Plan & Strategy, for the site to improve customer complaint, internal quality notification (CDT & R) and compliance metrics.
• Developing Pall Corporation’s relationships by working with customers to resolve & support complaint investigations and maintaining Pall Corporation’s excellent reputation with its customers (inc. OEM) for Pall.
• Providing leadership and technical expertise to the manufacturing operation on relevant Quality Systems improvements including licensing partners, customers and suppliers.
• Manage site specific QA/RA organisation to meet BU and site goals, clearly defined roles and responsibilities; and develop talent.

• QA / RA Management Consultant (Norrish Consultancy Ltd.) at Sense Biodetection (Cambs.)
• QA / RA Manager - Sense Biodetection – Molecular Diagnostics (Cambs.)
• Creation and initiation of organisation’s Quality Management System to comply with ISO 13485:2016 (Design & Development) and 21 CFR Part.820 Quality System Requirements (QSR).
• Providing consultancy and guidance to support company’s strategy towards certification and regulatory approval for IVD (Flu Virus) molecular diagnostic devices.

• Ensuring all global accreditations required for global medical device services are maintained, by addressing any related technical, regulatory and quality issues.
• Accountable for the maintenance and improvement of the Notified Body’s QMS processes covering 93/42/EEC, 98/79/EC, ISO 13485 and MDSAP schemes and working to transition to MDR.
• Liaison with external accreditation bodies and competent authorities (MHRA) to develop relationships with the Notified Body, to reduce non-conformities and improving global control and regulatory compliance throughout.
• Managing all on-site QMS / Technical File competent authority inspections received from MHRA and MDSAP regulators with collaborative interaction to resolve corrective actions.
• Developing direct reports (team) to initiate new working methods & approaches to improve team working, communication and interaction with wider SGS business.
• Accountable for Notified Body’s Unannounced Audit and Affiliate monitoring processes

• Accountable for improving and developing operational Key Performance Indicators for the Medical Devices Certification Business.
• Perform technical reviews of medical device assessment packs for changes impacting client certification status.
• Leading development and delivery of internal and external training packages for core certification products e.g. ISO 13485:2016.
• Managing and driving improvements in medical device auditors’ competency, training and qualification.
• Improving global relationships between Notified Body and global SGS affiliate offices to enhance global compliance.

• Accountable for leading the development of the site’s Quality & Environmental Management Systems to ensure compliance to; ISO13485, ISO14001, 21CFR, Japanese MHLW Ordinance 169, CMDCAS, IVDD and MDD Directives.
• Lead / Corporate Auditor with extensive experience in improving and influencing regulatory change, performance and quality system compliance for BD’s suppliers across Europe.
• Managing all on-site QMS / Technical File Notified Body inspections received from FDA, BSI, TÜV and SGS and associated corrective action responses.
• Overseeing the successful implementation of the product incident reporting (P.I.R.) process incorporating vigilance and risk management.
• Implementing a rigorous monitoring and evaluation system to challenge existing quality system processes. (E.g. CAPA & Internal Audit Program).
• Forging and establishing excellent regulatory links with all manufacturing sites in the U.S. and embedding best practice and standardisation, globally.

Plymouth, United Kingdom

• Proven success in project managing interdisciplinary teams to improve manufacturing processes quality and efficiency.
• Lead Additive Manufacture & Analytical Chemistry groups, in support of manufacturing the company’s leading diagnostic products.
• Continuous improvement of working practices and managing change to meet industry demands by improving analysis capability & graduate recruitment.
• Implementation of a structured coaching and mentoring programme to ensure specialist knowledge is applied across the business.

N.E. Lincolnshire, UK

• Extensive project management experience in the development and process optimisation of existing and new synthetic (API) chemical processes.
• Strong collaboration with multidisciplinary teams to ensure project deadlines are met.
• Successfully introduced and implemented chemical processes, prior to increasing capacity of pharmaceutical manufacture via a new synthetic route.
• Structured the required process documentation within c.GMP protocol. (Including process validation, process risk analysis, COSHH and Master Manufacturing Procedure (MMP)).

Haverhill, Suffolk, UK

Master’S Degree, Medical Technology Regulatory Affairs, (Graduated - June 26Th 2015)

M.Sc. Modules Studied: (i) Principles of European Medical Technology Regulatory Affairs (ii) Design Development and Testing of Medical.

Doctor Of Philosophy (Ph.D.), Organic Chemistry (Synthesis)

Ph.D. Research - Thesis Title : “New Methods for the Synthesis of Complex Amino Acids and Carbohydrates.” Research Publications to date.

Bsc (Hons), Applied Chemistry With Medicine

Including : (i) Research for CNRS at University of Poitiers (France) (April - Sept. 1993) (ii) British BioTech Pharmaceuticals - Oxford.