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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in qualification and validation of GxP-critical equipment and computerized systems, ensuring compliance with regulatory requirements and internal procedures. Strong problem-solving and communication skills are essential for collaboration with cross-functional teams and stakeholders.
Highest-signal resume keywords
Qualification And Validation ExpertiseGxP ComplianceDocumentation SkillsFluency In Finnish And EnglishRegulated Environment Experience
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 StrategiesQualification ActivitiesChange ControlPeriodic ReviewsRevalidationTechnical Project ContributionComputerized SystemsRegulatory Requirements
Soft Skills
Attention To DetailProblem-SolvingCommunication SkillsSolution-OrientedConscientious Working Style
Certifications & Qualifications
Approved Medical ExaminationSecurity Clearance
Industry Keywords
GxP-Critical EquipmentAuditsInspectionsManufacturing SitesLife Sciences
About the role
Key responsibilities & impact- Define validation and testing strategies for assigned projects
- Plan, perform, and lead qualification and validation activities for GxP-critical equipment and computerised systems
- Ensure validation documentation complies with applicable regulatory requirements and internal procedures
- Maintain the validated state of GxP-critical equipment and computerised systems through change control, periodic reviews, and revalidation
- Provide qualification and validation expertise during audits and inspections
- Contribute to technical projects as a validation expert
- Collaborate with QA, Automation, Own Manufacturing, external suppliers, project teams, and other stakeholders
- Travel mainly between manufacturing sites depending on project and phase
Requirements
What you’ll need- Relevant degree in engineering, technology, life sciences or a related field, along with relevant work experience
- Good understanding of GxP requirements
- Strong documentation skills and attention to detail
- Good problem-solving and communication skills
- Fluency in both Finnish and English
- Previous experience in qualification and validation, as well as with computerised systems in a regulated environment, is considered an advantage
- Solution-oriented, systematic and conscientious working style
- Comfortable taking responsibility, working independently, and managing multiple tasks and projects
- Motivated to continuously develop expertise in qualification and validation
- Approved medical examination including drug testing required prior to employment
- Security clearance required prior to employment for the selected person
Benefits
Comp & perks- Permanent, full-time position
- Possibility for hybrid working
- Excellent opportunities for professional development
- Collaborative and supportive team with strong professional expertise
- Wealth of career paths and development opportunities
- Safe working environment
- Work creating impact and well-being for customers, patients and society
- Approved medical examination and security clearance prior to employment for the selected person