qa engineer consultant

• Support QA Engineering in ensuring compliance with qualification, validation, and cleaning validation requirements across the full system life cycle (concept, project, operational, retirement).
• Review and approve qualification/validation and cleaning validation documentation (SOPs, user requirements, risk assessments, test plans, protocols, reports, change controls, CAPAs).
• Review and approve master data, recipes, and user procedures in systems such as MES, PCS, SAP, DeltaV, or similar.
• Participate in change controls and multidisciplinary project teams for new or upgraded systems, facilities, utilities, equipment, or processes.
• Provide QA guidance and support for preparation and execution of qualification/validation and cleaning activities, ensuring cGMP aspects are safeguarded.
• Address and follow up on deviations during qualification, validation, or cleaning activities.
• Communicate status updates (quality, compliance, planning) to relevant stakeholders and QA teams.
• You may also support audit management, the CAPA program, and regulatory inspections, while contributing to quality risk management and training initiatives.

• Degree in Life Sciences, Engineering, or related discipline.
• Experience in the chemical and/or pharmaceutical industry, preferably in QA, qualification/validation, or cleaning validation.
• Knowledge of cGMP regulations, data integrity, and pharmaceutical quality standards.
• Ability to analyze complex issues, identify root causes, and develop effective solutions. This includes a systematic and logical approach to problem-solving.
• Ability to translate technical information into clear communication across different levels of the organization.
• Strong organizational skills with the ability to multitask and prioritize.
• Independent, detail-oriented, and effective in cross-functional team environments.
• Strong communication skills, fluent in English and Dutch (spoken and written).

Systems Knowledge

• Manufacturing, laboratory, facility, utility, IT/automation systems (e.g., MES, SAP, DeltaV, PCS, LIMS).
• Problem and change management tools (e.g., Trackwise, Comet).
• Document management systems (e.g., TruVault).
• Validation test tools (e.g., Kneat).

• A market competitive salary according to PC200
• Hospitalization insurance
• Group insurance
• 32 days of leave (20 legal + 12 extra)
• Meal vouchers
• Training opportunities
• FIP (= Flexible Income Plan)