Michael Low Email & Phone Number

Falkirk, Gb

Edinburgh, Scotland, United Kingdom

Morpeth, England, United Kingdom

Runcorn, England, United Kingdom

Inverness, United Kingdom

Continuation of previous role as detailed below, additionally providing validation support and guidance for the migration of J&J systems to Lifescan cloud-based platforms.Responsible for the review and remediation of IT, Laboratory and Manufacturing based systems.Provide training to the organisation on validation best practice with particular focus on computerised system validation.

Responsible for the regulatory compliance and validation of business critical systems including quality management systems, process / control systems, SCADA systems, facility monitoring systems, laboratory systems and end user systems to EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines and 21 CFR Part 210.Generation and execution of validation documentation (URS, VP, FMEA, FAT, IQ, OQ, PQ and VSR)CSV Lead on the remediation of laboratory systems including spectrophotometers, TOC analysers and mass spectrometry and separator systems to data integrity standards.Managed and coordinated the validation activities for facility monitoring systems (Eurotherm) used within the pharmaceutical production area. Performed periodic validation review and requalification activities as per EudraLex - Volume 4 Annex 15.

Inverness, United Kingdom

Providing focus and activity management for the validation activities associated with software systems, automated manufacturing equipment, and quality systems used within a regulated environment, ensuring that all compliance issues and requirements are addressed.Provide validation strategy and guidance to system owners, project managers and project teams with regard to FDA & EU medical device regulations, J&J Corporate and Local company policy requirements & responsibilities to ensure compliance.Responsibilities and tasks within this role include –o Coordinating projects associated with the validation of computerised systems and automated manufacturing systems.o Participating and providing the lead on validation working parties associated with computer systems, working closely with cross functional groups, and providing a timely validation coordination service to Project Managers or identified Project Leaders to ensure customer requirements are met.o Providing guidance and support on current regulatory and company standards that must be met to achieve and maintain compliance.o Assisting with the preparation and issue of documentation associated with the validation of computer systems and automated manufacturing equipment, as appropriate for each validation projecto Assisting project teams with change management activities associated with the validation of business systems, ensuring project activities adhere to company policy and procedures.o Participating and leading improvement activities related to the quality system including improvements to cross franchise validation processes.o Ensuring all validation activities and documents are authorised and appropriate compliance approval is gained.o Ensuring that all validation activities are carried out and reported to management in a timely manner.

Supported site wide quality management systems and processes used throughout the Lifescan organisation.My role as Project Manager involved managing the implementation of several site wide computerised quality management systems including a new EDMS system (Master Control) and Complaint Investigation/NC/CAPA/Audit system (NetRegulus), as well as the on-going maintenance and support of these systems to ensure system compliance, integrity, reliability, and day-to-day system access for business users.

Computer Science

Hnc In Computing

ISO 9001: 2000 Quality Management Lead Auditor Microsft Certified Professional Process Excellence - Green Belt Certified