Description
ESSENTIAL DUTIES AND RESPONSIBILITIES:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
? Must have 5+ years recent experience in validation of product/processes/equipment within the medical devices industry
? Must have ability to analyse and interpret data
? Must have good interpersonal and organisational skills
? Must have proficient computer skills ( MS office etc)
? Education - degree qualified - Science / Engineering
DESIRED MINIMUM QUALIFICATIONS / EXPERIENCE
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
? FDA validation requirements & understanding
? Software validation requirements
? Development of IQ/OQ and PQ protocols
? Performance of qualification activities
? Validation report writing
? Process FMEA
? Risk management
? SOP/specification development
? Document/change control
? CAPA
This is an urgent position with hourly rates between 30-40 EUROS per hour. If you are interested or know anyone who might be, please contact Sarah Irvine on .