Compliance & Validation Specialist
HybridMalmö, Skåne, Sweden
Job Summary
Compliance & Validation Specialist responsible for securing regulatory compliance across enterprise systems with a primary focus on the new ERP program. Develop and execute validation strategies for GxP-relevant systems (CSV) in accordance with GAMP 5; author and review IQ/OQ/PQ protocols, validation plans, traceability matrices, and summary reports; ensure compliance with electronic records and signatures (21 CFR Part 11, EU Annex 11); perform risk assessments and integrate validation into change control; maintain audit-ready documentation and support regulatory inspections and CAPAs; collaborate with Global QA, regulatory affairs, IT, and external vendors to align on validation requirements and documentation standards; provide training on validation procedures and regulatory expectations.
Required Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Science, or similar
- 5+ years of experience in IT compliance, system validation, or QA in biotech, pharma, or another regulated industry
- Solid knowledge of GxP, GAMP 5, 21 CFR Part 11, and EU Annex 11
- Experience with computerized system validation (CSV) and quality documentation
- Familiarity with enterprise platforms like ERP, MES, LIMS, or QMS
- Full professional proficiency in English
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