Validation Expert Analytical Lab

Ben jij klaar voor de volgende stap in jouw carrière? Als technisch specialist in de Life Science-sector werk je aan technologieën die levens verbeteren. Je speelt een sleutelrol in de ontwikkeling en optimalisatie van systemen voor bijvoorbeeld geneesmiddelenproductie, medische apparatuur en biotechnologie. Jouw werk is cruciaal voor het succes van deze projecten.

Verantwoordelijkheden

• As a Validation Expert Analytical Lab, you are responsible for setting up and writing validation protocols, analyzing validation results, and drawing well-founded conclusions.
• You write validation reports for analytical method validation and method transfers.
• You perform cleaning validation activities, including sample preparation, HPLC analysis, and processing HPLC data using Empower software.
• You analyze data and create reports as part of the annual review (reduced testing program).
• You respond to internal and external enquiries regarding analytical results and processes.
• You review data generated by other analysts in the team to ensure accuracy and compliance.
• You develop and/or review departmental documentation, including lab data sheets, training materials, SOPs, change controls, deviations, and CAPAs ensuring compliance with GMP and relevant regulatory guidelines.
• You assess compendial changes, perform method verifications, and provide training to analysts.
• You offer analytical technical expertise in pharmacopoeial testing, regulatory requirements, investigations, change control, and root cause analysis.
• You share key findings and successes with other departments during report-out sessions with management.
• You organize and lead method transfer project meetings and participate in related conference calls.
• You attend daily communication meetings to stay aligned with project updates and team priorities.
• You work in accordance with applicable safety guidelines and GMP standards.

Vereisten

• Master’s or Bachelor’s degree in Chemistry, Sciences, Pharmaceutics, or equivalent through experience. 
• Min. 2 years’ experience in an Analytical Lab. 
• Hands-on experience with HPLC and method validation. 
• Skilled in Empower Software. 
• Knowledge of Pharmacopeias (USP, Ph. Eur., JP) and cGMP requirements. 
• Experience with writing validation protocols, SOPs, and reports. 
• Accurate, proactive, and a true team player. 
• Able to work independently and solve problems effectively. 
• Well-organized and capable of multitasking. 
• Fluent in Dutch & English. 

Bij STAR staat jouw carrière centraal. Wij verbinden je met uitdagende projecten, bieden persoonlijke begeleiding en creëren kansen bij opdrachtgevers waar je trots op bent.

Samen zorgen we ervoor dat jij het beste uit je carrière haalt.