Education:
Bachelor's degree in a scientific or engineering discipline, or equivalent experience.
Experience:
3-5 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.)
experience
7show more
Education:
Bachelor's degree in a scientific or engineering discipline, or equivalent experience.
Experience:
3-5 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.)
experience
7