2 of 2 21 CFR Part 11 Jobs in Haverhill

assessments, validation planning and test execution. Maintain documentation including SOPs, validation records, configuration specifications and change records. Ensure compliance with GMP, GAMP 5, Annex 11, 21 CFR Part 11 and company quality procedures. Support internal audits, external audits and regulatory inspections. Project and Vendor Management ...

Experience working within a pharmaceutical, biotechnology, medical device or similarly regulated environment would be highly desirable An understanding of GxP, GMP, GAMP 5, Annex 11 and 21 CFR Part 11 would be advantageous Strong understanding of IT service management and ITIL principles Excellent analytical ...