Analytical Method Validation Specialist
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Job Description
We are seeking an experienced Analytical Method Validation Specialist to support Quality Control (QC) Operations within a leading pharmaceutical manufacturing environment. The successful candidate will be responsible for coordinating and authoring analytical method validation activities, ensuring compliance with GMP requirements and supporting continuous improvement initiatives. This role offers the opportunity to work closely with laboratory teams, statisticians, quality representatives, and project stakeholders while contributing to critical validation projects and quality excellence programs.
Key Responsibilities
Analytical Method Validation Documentation Author and maintain validation-related documentation including: Validation protocols Validation reports Amendments Risk assessments Scientific rationale reports Technical instructions Periodic review documentation Raw data review documentation Comparability protocols and reports QC material qualification documentation Validation Project Coordination Coordinate validation activities across multiple stakeholders. Collaborate with laboratories, project teams, quality representatives, and statisticians. Monitor validation studies and experimental progress. Coordinate pre-tests, validation studies, data collection, and reporting activities. Analyze validation results and ensure appropriate documentation of outcomes. Quality Systems Support Support and coordinate quality events linked to validation activities, including: Deviations Change Controls (CC) Corrective and Preventive Actions (CAPA) Participate in investigations and associated meetings. Ensure compliance with internal quality systems and GMP expectations. Review & Compliance Activities Participate in peer review and quality review of validation documentation. Contribute to maintaining the validated state of analytical methods. Support risk-based decision making for method lifecycle management. Continuous Improvement Participate in operational excellence and continuous improvement projects within QC Operations. Identify opportunities to enhance validation processes, documentation quality, and operational efficiency. Qualifications Master’s degree in chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or related scientific discipline. Minimum 3-5 years of experience in pharmaceutical Quality Control, Analytical Development, Validation, or Quality Assurance. Strong experience with analytical method validation in a GMP-regulated environment. Experience authoring technical and validation documentation. Experience with Change control, Deviation Management and CAPA management. Fluent communication skills in English. French is a plus. Additional Information A full-time (40hours/week) Monday – Friday job. A Permanent contract with flexible
working hours
. (Can start between 7am and 9:30am) Place of work: Wavre, Belgium. Meal Vouchers 8 Euro/Working Day. Eco-Cheques +/
- 250 Euro/Year. DKV Hospitalization insurance. Additional 12 ADV days. A company well-being program targeting both mental and physical well-being. Access to Payflip, an innovative app that helps you take control and optimize your paycheck. A fantastic team with monthly team lunches, fun teambuilding activities (laser tag, escape rooms, sports, etc.) and above all; a great collaborative international work environment Personal development through learning on the job and additional trainings. And more.
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