Computer Systems Validation Consultant

Job Summary: Interprets and understands relevant GxP regulations and standards and provides coaching/guidance to ensure enforcement and consistent application of GxP requirements Executes, manages and documents the periodic reviews of global GXP IT systems Review and provide coaching/oversight for non-GxP changes (MOCs) Authors and/or reviews GxP technical documents (SOPs, Work Instructions, Risk Assessment, URS, CS, DS, IOQ, PQ/UAT, RTM, Reports, etc.) as assigned. Provide GxP project support for CSV systems (new implementations, upgrades, decommission, etc.) as assigned Provides quality review of relevant validation documentation pre and post execution for accuracy, completeness and to ensure compliance with regulatory and MNK requirements. Collaborate w/ department personnel (QA, IT, Operations, etc.) for assigned projects Maintains and periodically updates global CSV inventory, as required. Other duties may be assigned, as required.Job Requirements: Minimum requirement is a Bachelor's Degree in Computer Science, Sciences or a related education. Minimum 5 years Professional experience in managing quality / compliance in the regulated environments in a Pharmaceutical/Life Sciences Organization. Proficiency in Computer System Validation in a GXP environment. Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles. Strong knowledge of GMP, GAMP5, SOPs and quality systems. Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10). Strong knowledge of IT compliance SOPs including change control practices/strategies, and system risk assessments. Proficient in MS Word, Excel, Power Point and other applications. Strong written and verbal communication skills. Ability to communicate and work independently with scientific/technical personnel. Ideal candidate will have experience in validating software applications like SAP, Master Control (MC), and Compliance Wire (CW). Prior experience in managing Data Migration and Archiving related projects. #ZRWe are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion, color sex, national origin, citizenship status, age, sexual orientation, gender identity, marital status, uniform service member status, genetic information, disability, or any other protected status, in accordance with all applicable federal, state, and local laws. This practice extends to all aspects of our employment practices, including but not limited to, recruiting, hiring, firing, promoting, transferring, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.