FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in validation activities for GxP-regulated computerized systems, ensuring compliance with quality and regulatory requirements through effective documentation, testing, and collaboration with cross-functional teams.
Highest-signal resume keywords
GxP RequirementsValidation PlansRisk AssessmentsQuality Assurance MethodologiesData Integrity Principles
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Validation DocumentationSystem TestingRequirements VerificationTest ScriptsValidation ReportsData CollectionProject Quality ManagementPlanning and OrganisationRisk-Based PrinciplesContinuous Improvement
Soft Skills
Collaboration SkillsCommunication SkillsDecision-MakingAccountabilityProblem-Solving
Tools & Technologies
ERP SystemsMES SystemsLIMS SystemsGAMP 5EU GMP Annex 1121 CFR Part 11
Industry Keywords
GxP-Regulated SystemsValidation StandardsQuality ComplianceRegulatory RequirementsManufacturing Systems
Tech Stack
Tools & technologiesERP
About the role
Key responsibilities & impact- Plan, coordinate and carry out validation activities for new and existing GxP-regulated computerised systems.
- Develop, review and maintain validation plans, risk assessments, protocols, test scripts, reports and traceability matrices.
- Perform system testing and verification to confirm that systems meet defined business, quality and regulatory requirements.
- Support audits, inspections and regulatory enquiries by providing validation evidence.
- Work with Quality, Manufacturing, Engineering, IT and external vendors to assess changes and embed validation requirements throughout the system lifecycle.
- Contribute to validation standards, processes, best practice and continuous improvement.
- Help ensure Norgine’s GxP-regulated computerised systems, equipment, validation documentation and associated processes meet applicable quality and regulatory requirements.
- Provide practical validation expertise throughout the system lifecycle and apply risk-based principles to support compliance, data integrity and operational effectiveness.
Requirements
What you’ll need- A bachelor’s degree, or equivalent qualification or experience, in computer systems, engineering or a related discipline.
- Experience working with relevant procedures or systems.
- Competence in quality assurance methodologies, review and reporting, data collection and analysis, planning and organisation, requirements verification and project quality management.
- Ability to interpret complex information, make sound decisions and identify appropriate actions.
- Strong collaboration and communication skills, with the confidence to raise compliance concerns when required.
- A structured, accountable approach to documentation, testing and delivery.
- Working knowledge of GxP requirements, data-integrity principles and relevant guidance, including GAMP 5, EU GMP Annex 11 and 21 CFR Part 11.
- Experience producing and executing validation deliverables, including risk assessments, protocols, test scripts and validation reports.
- Familiarity with manufacturing, laboratory, quality, ERP, MES, LIMS or other regulated computerised systems.
Benefits
Comp & perks- Ongoing development within a supportive and inclusive environment
- Opportunities to develop your career
- Work contributing to a meaningful difference to patients’ lives
- Benefits may vary per location; further information available from the Norgine TA representative