We are seeking a Validation Expert for a Global Medical Device company that is looking for a consultant with a Quality and Regulatory background that is strong in validations - specifically IT Validation.
The project is to ensure the quality management system is built to the highest standard liaising with internal stakeholders adhering to external quality system requirements.
Location: Home-based - with occasional travel to the South of the Netherlands
Duration of employment: 6 Month Rolling Contract
Responsibilities as a Validation Expert
*Provide guidance, review and approval of validation deliverables including; Classification, Risk analysis, Part 11 assessment, Validation Plan, User Requirements Specification, Validation Summary Reports
*Ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process in compliance
*Support cross-Philips setup and deployment of the Quality Management Systems along business model lines as identified
*Translating 21 CFR Part 11 & 21 CFR Part 820 to IT requirements
*Implementing GAMP 5, V-model methodology and guidance documents: GPSV / AAMI TIR36.
*Ensuring the quality management system adheres to ISO 13485, ISO 14971, ISO 900
*Liaising with senior stakeholders across the business in multiple time zones
*Applying Project Management Methodologies ( SDLC, Agile)
Skills and Experience Required as a Validation Expert
*Minimum of 3-5 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical (device/Pharma) industry.
*Bachelor's degree or equivalent preferably in a technical or engineering or/and IT related field(s).
*Good communication skills written & verbal in English
*Hands on experience with end to end lifecycle of software validation ( Development , Operations/ Maintenance, Upgrade , Retirement)
*This position requires an extensive knowledge of FDA QSR's, ISO 13485, JPAL, China GMP's and other worldwide Quality System Regulations.
*Software validation experience
*Knowledge of 21 CFR Part 210 , 211
*Experience in working directly with FDA/MHRA/ TGA/ ANVISA/other regulatory inspections (desirable)
*Auditing experience, either in supporting or doing audits (desirable)
*Awareness of Lean methodologies (desirable)
How to apply
Apply here if you are interested in this opportunity please apply on the link below or if you would like a confidential discussion about your career opportunities please contact Isabel Kennedy of EPM Scientific.
Disclaimers: Must have the rights to Work in Europe
