Compliance & Validation Specialist

Develop and execute validation strategies for GxP-relevant systems in accordance with GAMP 5 and biotech/pharma industry standards. Author and review validation documentation such as validation plans, IQ/OQ/PQ protocols, traceability matrices, and summary reports. Ensure systems comply with electronic records and signature regulations (21 CFR Part 11, Annex 11) and perform risk assessments for new systems, upgrades, and system changes. Maintain audit-ready documentation and support both internal and external audits, including regulatory inspections, while addressing findings through corrective and preventive actions. Collaborate with Global QA, IT, regulatory affairs, and external vendors to align on compliance and validation requirements. Provide training and guidance on validation procedures, regulatory expectations, and documentation standards. Join the global IS/IT team in Malmö or nearby sites to secure the new ERP platform for a specialized CDMO serving pharma and biotech customers.