Description
RESPONSIBILITIES:? FDA validation requirements & understanding
? Equipment, facilities & CSV
? Development of IQ/OQ and PQ protocols
? Performance of qualification activities
? Validation report writing including Validation Master plans
? Risk Assessment
? SOP/specification development
? Document/change control
? Building Management Systems (BMS)
? CAPA
REQUIREMENTS:
? Must have 5+ years recent experience in validation of facility/CSV/equipment validation within the Pharmaceutical or Medical Device industry.
? Must have the ability to analyse and interpret data.
? Must have proficient computer skills (MS office etc).
? Education - degree qualified - Science / Engineering.
This is an urgent position so if you are interested or know anyone who might be, please contact Sarah Irvine on .