Senior Design Assurance Engineer (CTM) @ Biotronik Schweiz AG
Senior Officer (Manager) Quality Compliance Team @ Edwards Lifesciences
Quality Assurance and Validation Specialist @ Wyeth Pharmaceuticals
A Senior Analyst with over 10 years Quality Assurance and packaging technology experience within supply chain: Self-disciplined and an effective time-manager. Experienced in working in highly pressurised environments, within strict deadlines and regulations. Demonstrating a ‘hands-on’ approach to work and the drive to achieve goals and improve processes: A practised team-leader and qualified trainer with the ability
A Senior Analyst with over 10 years Quality Assurance and packaging technology experience within supply chain: Self-disciplined and an effective time-manager. Experienced in working in highly pressurised environments, within strict deadlines and regulations. Demonstrating a ‘hands-on’ approach to work and the drive to achieve goals and improve processes: A practised team-leader and qualified trainer with the ability to motivate others to achieve key objectives. Able to work in teams or independently with a analytical approach and a keen eye for detail.
A chemistry graduate with a strong analytical background, and an appetite for new challenges, relishing a position which requires creative problem solving.
Specialties: Quality Assurance, Compliance, Risk Management, Packaging Technology and Supply Chain.
Senior Officer (Manager) Quality Compliance Team @ Reporting directly to the site Quality / Regulatory Affairs Director and assuring compliance for the Edwards manufacturing site at Horw. Owner of the Quality process, (CAPA, Deviations, Change Control, Internal, External and Corporate Audit program, Complaint process, Data administration and Training for the Quality department) and reporting of quality indicators to Senior Management.
Senior Officer Quality Compliance responsibilities include:
- Process owner for the Quality Management System (QMS)
- Process owner for the Internal, External and Corporate audit program
- Alignment and management of the Process Failure Mode and Effect Analysis (PFMEA)
- Organization of Regulatory Inspections
- Quality overview of Label Design including the change control process (Ignite super-user)
- Team Manager responsible for the Data administration team
- Process owner for Non-Conformance investigations and metrics
- Responsible for the collation and reporting of monthly and quarterly metrics to the site Senior Management team in Horw and the Executive Leadership team in Irvine.
Interim QC Manager responsible for:
- Daily active of the QC Inspectors across the 3 shifts (18 Inspectors in total).
- Compliant manufacturing of heart valves and annuloplasty rings inline with ISO13485
- Receiving inspection for production parts
- Release of products into the European market as well as RoW
- Liaise with other departments for all internal quality related topics and support the continuous improvement of the QMS
- Investigation OOT's, OOS's and ensure prompt follow up. From June 2014 to Present (1 year 5 months) Horw, switzerlandSenior Analyst, Clinical Logistics @ Quality Assurance
Quality review of qualification reports used in the distribution of products from various contract manufacturing organizations (CMO’s) to global destinations.
Streamlined deviation process and act as subject matter expert (SME), for review of all supply chain deviations.
Quality review of all CMO’s deviation reports.
Liaise with Quality Assurance (QA) to ensure thorough investigations are actioned with the appropriate corrective and preventative actions (CAPA) being implemented.
Process improvement at all CMO sites with the implementation of CAPA actions and drafting of validation test protocols where appropriate.
Established a dedicated process for the quality approval of all new CMO and company owned shippers.
Project manager for the implementation of a temperature monitor database.
Execution of validation protocols ensuring the suitability of shipping systems, when deviating from recommended use, due to the complex nature of the product requiring distribution.
Implementation of SOP’s for use in temperature controlled distribution.
Perform risk assessments on equipment and processes to ensure business continuity
Implementation of a global temperature profile for shipper qualification and authoring a supporting SOP’s.
Liaise with the CMO’s for temperature controlled distribution related issues, with the direct involvement of the design and qualification of the shippers.
Implementation of a risk based approach for global airfreight shipments.
Management of stability records for use in temperature deviations and authored supporting SOP's
Monthly trending of deviations and CAPA implementation.
Presenting on department’s deviations and CAPA recommendations. From August 2010 to April 2014 (3 years 9 months) Zug, SwitzerlandQuality Assurance and Validation Specialist @ Quality Assurance
Qualification of temperature controlled shippers ensuring the qualification was in-line with the good distribution practices (GDP) requirements.
Review of temperature monitoring process and streamlining the operation in its entirety.
Qualification of a range of high performance temperature controlled shippers.
Sites change control process and quality approval of all change controls.
Subject matter expert (SME) for the investigation of all in-transit deviations.
Established a global temperature profile reflecting the distribution practice
Implementation and execution of validation protocols for equipment qualification and process validation connected with primary and secondary packaging operations.
Implementation of a quality investigation process, with the introduction of TrackWise as part the process improvement initiative.
SOP author and approver. From January 2008 to August 2010 (2 years 8 months) Horsham, West Sussex, EnglandQuality Assurance and Validation Specialist @ Quality Assurance
Project manager for the development of supply chain distribution components, ensuring compliance with GDP requirements.
Investigating all in-transit deviations and implementing appropriate CAPA.
Qualification of proposed shipment routes and issuing qualification reports.
Capture and analysis of all temperature data on distributed shipments and issuing monthly reports.
Responsible Person for all European Affiliate excursions.
Supervise staff ensuring appropriate training is undertaken.
Mentoring staff with regular one to ones and yearly appraisals.
Temperature controlled import, export and return to site shipments for the site.
Implementation of a global, audit compliant qualification system (Geozone) for the distribution of temperature controlled products.
Distribution of controlled drawings for use in temperature controlled shipments in conjunction with the Geozone system.
Authoring and review of SOP’s and ensuring training is carried out where appropriate. From November 2002 to December 2007 (5 years 2 months) Havant, Hampshire EnglandSenior Analytical Chemist @ From April 1997 to April 2002 (5 years 1 month) Farlington, Hampshire, England
Bachelor of Applied Science (B.A.Sc.), Applied Chemistry @ University of Portsmouth From 1991 to 1996 Stuart Harrison is skilled in: Validation, Sop, CAPA, Clinical Trials, GMP, Quality Assurance, Change Control, Cold Chain, FDA, GxP, Supply Chain..., Trackwise, Packaging Technology, Deviation Management, Temperature controlled..., GDP, Investigation Management, Packaging Engineering, Quality Control, Process Improvement, Continuous Improvement
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