CSV Compliance Specialist

Job Title: CSV Compliance Specialist Location: Decatur, Illinois, United StatesJob Type : 6+ months Contract

JOB DESCRIPTIONCSV Compliance SpecialistOur client is a mid-sized pharmaceutical company, who just underwent a large acquisition. They are seeking a highly motivated and experienced CSV Compliance Specialist to validate and revalidate GxP Computerized Systems and on-premises IT infrastructure at a newly acquired facility. This individual will be responsible for validating and revalidating the GxP Computerized Systems and on-premises IT infrastructure, and will play a pivotal role in projects, programs, and support work related to Computer System Validation. This role reports into the Sr Manager of IT Quality and Validation. This person must be capable of validating/ revalidating GxP Computerized Systems located in QC, laboratory, manufacturing, warehouse, engineering, QA, IT departments, and therefore should have relevant experience within these spaces. Other requirements include:qualifying/ re-qualifying cloud-based environment IaaS, SaaS, PaaSReview validation deliverables in project initiation phase - User Requirement Specifications (URS) and GxP Assessment, Functional Specifications, Design Specifications, Configuration Specifications, Technical Specifications, etc. Preparing or reviewing validation deliverables in testing phase – Protocols and Test Scripts for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Requirement Traceability Matrix (RTM) report, 21 CFR Part 11 Assessment, Summary reports. Required SkillsetThe must haves! Computer Systems Validation 7+ yearsProficient in Technical Writing, MS Office and Adobe documentation softwareAuthor, Execution, & Review of CSV SOP’s, Templates, Change Controls, Deviation tasks, CAPA tasksKnowledge of Compliance Guidance's related to CSV21 CFR Part 11EU Vol4 Annex 11ISPE GAMP5,PIC/s,ICHQ9Must have excellent English communication skills (written and spoken)