Sr. Manager, CSV & QA

Sr. Manager, Computerized Systems Validation & QA (Florham Park, NJ) – Analyze and perform quality assurance and validation functions in computerized systems in support of pharmaceutical manufacturing GxP guidelines, QMS (Quality Management Systems),  and equipment in accordance with FDA/EMA/PMDA/ICH regulations, 21 CFR part 11; Develop and implement validation programs and qualification tools to improve process monitoring and optimization using Data Integrity controls; Review Change Control requests and assess impact to validation using SNOW Change Management process compliance; Perform internal quality control and Site Audit Planning using Supplier Audit Risk Assessment and Internal Auditor ISO 27001:2013; Develop and implement Corrective and Prevention Action (CAPA) and Root Cause Analysis procedures using principles of FMEA (Failure Mode Effective Analysis), Change Control; Perform Quality Assurance oversight for GxP computerized system activities using Veeva Vault, GAMP assessment; Review and perform risk analysis/risk management on Change Controls, CAPAs, deviations, and Notice of Events (NOEs) using; Validate GxP computerized systems, Clinical Data Management Systems, RAVE, SAP, LIMS; Support regulatory body inspections; Perform gap analysis of validation documentation, systems and practices.

Must have a Bachelor’s degree in Computer Science, Information Technology, or Software Engineering plus 5 years experience in computer system validation in GxP related environment. Require skills and knowledge of Change Control, Supplier Audit Risk Assessment, 21 CFR Part 11, Data Integrity controls, GAMP, QMS.

Job location: Florham Park, NJ. Standard company benefits with $150k~$153k/year. Submit résumé referencing job code SRV002 to HR, Shionogi, 400 Campus Dr, Florham Park, NJ 07932.

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