*JobTitle : Validation Analyst. Location: Cambridge, MADuration:6+ Month
(Contract)*
Job Requirements:
As a member of the IT Quality & Regulatory Compliance team, the IT Analyst
Regulatory Compliance helps to define, plan, and perform duties that
support major system development life cycle activities, including
validation review and change control approval of IT systems.
PRINCIPAL DUTIES & RESPONSIBILITIES:
• Approve system life cycle deliverables and activities to ensure that
regulations, protocols, procedures, and methodologies are followed, and
that appropriate and complete documentation is captured and reported to
support validation activities.
• Represent IT Quality & Regulatory Compliance on cross-functional teams in
support of SDLC activities.
• Consult on the authoring and conformance of validation-related
deliverables and activities in regard to corporate SOPs and current
regulations.
QUALIFICATIONS:
• 5+ of experience in computerized system validation within a regulated
environment
• Salesfore.com AND/OR Veeva CRM experience is a MUST
• Strong knowledge of SDLC Agile methodology
• Detailed knowledge of the IT system development life cycle and software
quality assurance in a regulated environment
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