Sr. Manager, CSV & QA
Sr. Manager, CSV & QA
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Salary Not Disclosed
1 Vacancy
Job Description
Overview
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.
Responsibilities
Must have a Bachelors 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 rsum referencing job code SRV002 to HR Shionogi 400 Campus Dr Florham Park NJ 07932.
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EEO
Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race color religion sex (including pregnancy) marital status national origin age ancestry citizenship disability genetic information status as a disabled veteran a recently separated veteran Active Duty Wartime or Campaign Badge Veterans and Armed Forces Service Medal Veterans or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal state and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are in fact non-discriminatory.
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Required Experience:
Manager
Employment Type
Full-Time
