Education:
Bachelor's degree in a scientific or engineering discipline or equivalent experience.
Experience:
35 years of proven experience in QA review/approval of validation deliverables within a
regulated industry such as pharmaceuticals biotechnology medical devices or other
relevant sectors.
Experience in computer system validation using GAMP 5
Experience in infrastructure qualification
Experience with Quality Systems (e.g. change control deviations CAPA)
Knowledge Skills Abilities
Knowledge with quality and IT frameworks approaches tools methodologies (i.e. agile
waterfall GAMP ISO ITIL SDLC COBIT Computer Software Assurance (CSA) etc.)