Verification / Design Assurance Engineer
Swindon
Immediately available
£60-65 p/hour
Outside IR35
A pragmatic Pharmaceutical & Medical Devices professional. Broad cross departmental experience over the last 20+ years, spanning QA; RA; Operations; Manufacturing Management; Process and Production Support; Project Management; Validation (full range); Tech Transfer; QP training; problem solving/trouble shooting and CI/Kaizen et al.
• Process Validation
• Quality Engineer
• New Product Introduction
• Assure project/product development process follows appropriate design control disciplines as specified by FDA 21 CFR 820 & ISO 13485
• Writing and executing relevant documentation for the Commissioning, Qualification and Validation of a sterile aseptic filling line
• Quality Engineering support for the ‘Technical Transfer’; ‘Scale Up’; ‘Customisation’ and ‘Capacity Expansion’ of multiple injection moulded processes and components.
• Responsibility and review/sign off of all stage of Validation process (VP/FAT/SAT/IQ/DoE/OQ/PQ/VPCR) of tools sets and components.
• Quality Representative and contact point for project team managing external vendors & contract moulders.
• Quality/Validation Representative for Design History File Review panel.
• Review and sign off of key stage gate validation documentation from external vendors.
• Statistical assessment and presentation of validation results via use of Minitab.
• Authoring of multiple Technical Agreements between company and vendors, and development of associated manufacturing specifications in line with current/best practise.
