IT Quality & Compliance Analyst (Project Management)
The IT Quality and Compliance Analyst performs a variety of activities to ensure IT adheres to all relevant Sox and FDA compliance requirements in addition to overall IT Policy and SOPs.
Computer Systems Validation activities including but not limited to; Facilitate CSV Risk Assessments to classify systems and determine validation requirements; Author and / or review validation project and change artifacts for GxP systems such as requirements, designs, trace matrix, test plans and results and system release letters. Partner with QA to continuously improve IT CSV practices.
SOX Compliance activities including but not limited to; Review changes to SOX systems to ensure compliance with internal audit and SDLC requirements, work closely with internal audit to ensure successful and timely audits and resolution of findings.
IT Quality activities including but not limited to; Maintain IT documentation in appropriate repositories, educate and train IT associates on regulatory requirements and related SOPs, assist in development of IT SOPs and work with IT colleagues to continuously improve the quality of IT services.
Bachelors Degree (BA/BS) Bachelor's degree in a Technical/Science related field (e.g. Computer Science, Engineering, Chemistry, etc.) - Preferred
3 years or more in an IT CSV related role within Pharma.
3 years or more of experience across the CSV lifecycle, SDLC for S, producing,validation related documentation experience with Software Development Life Cycle Management and CFR 21 Part 11 compliance.
1 year or more in a SOX compliance role, experience to include reviewing and approving SOX changes and liaising with internal audit.
Excellent oral and written communication skills. - Intermediate
Knowledge of relevant GxP regulations and guidance to include but not limited to GAMP 5 and 21 CFR Part 11 Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5. - Intermediate
Ability to work with diverse group of stakeholders to elicit requirements. - Intermediate
Excellent attention to detail, organizational skills, and the ability to handle multiple projects/tasks in a timeline-driven environment. - Intermediate
Ability to create and edit documents in accordance with good documentation practices (GDP). - Intermediate