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Global IT QA
Centrient Pharmaceuticals. Provide QA governance to CSV and eDI practices for Global GMP systems .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Computer System Validation and Data Integrity within the Pharmaceutical industry, ensuring compliance with GxP regulations and effective governance of Global IT systems. Provides leadership in quality improvement initiatives and training on CSV processes.
Highest-signal resume keywords
Computer System ValidationData IntegrityGxP Analysis21 CFR Part 11SAP
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Computer System ValidationData IntegrityGxP AnalysisGap AssessmentRisk AssessmentQuality ImprovementChange Control GovernanceAudit PlanningTraining OrganizationTechnical Subject Matter Expert
Soft Skills
Strong Communication SkillsIntercultural SkillsIndependent WorkerTeam PlayerLeadership
Tools & Technologies
SAPDocument Management SystemCAPA Management Systems
Industry Keywords
Pharmaceutical IndustryGMP ComplianceCSV – GAMPGlobal IT SystemsCorporate Audits
About the role
Key responsibilities & impact- Provide QA governance to CSV and eDI practices for Global GMP systems
- Participate in Global IT projects involving new systems and changes
- Participate in Global IT quality improvement projects
- Ensure Change Control governance with Local site QA, IT, and Business Owners
- Act as System Subject Matter Expert on systems Quality and Validation
- Organize trainings on CSQ processes
- Define and maintain the GMP compliancy audit agenda for Centrient sites, business units, and Qualified Vendors
- Participate in CSQ and core business process project teams to identify and execute validation activities
- Provide leadership and technical SME support to Global CSV and DI improvement projects
- Participate in Corporate Audits, including computerized system audits
- Provide IT CSV support for agency audits, including multiple international agencies simultaneously
- Establish a clear and effective computer system validation framework
- Coach and train direct colleagues and Key-Users
- Audit CSV and eDI for Local Sites, System Vendors, CMO, CLO, and Global IT
- Support compliance of Global IT systems with applicable regulations and external inspection and audit support
- Plan, execute, report, and monitor audits
Requirements
What you’ll need- Working knowledge of Global IT systems (SAP, Document Management System, CAPA Management Systems)
- Strong Quality and continuous improvement mindset
- Deep expertise in Computer System Validation and Data Integrity for the Pharmaceutical industry
- Independent and reliable worker
- Team player
- Strong communications skills
- Intercultural skills
- Good Knowledge of GxP Analysis, Gap Assessment, Risk Assessment
- Good Knowledge of 21 CFR Part 11, CSV – GAMP and electronic Data Integrity
- 8 to 15 years of experience
- University degree in technical, science, chemical engineering or computer sciences