Quality Assurance Engineer – Contract
Assignment Overview
The QA Engineer will support the Quality Assurance Engineering function in ensuring that all qualification-related regulatory and procedural requirements are fulfilled throughout the full lifecycle of manufacturing systems (concept, project, operational, and retirement phases).
The role focuses on maintaining compliance and quality standards within a pharmaceutical manufacturing environment.
Key Responsibilities
Qualification & Compliance Oversight
* Review and approve qualification documentation and quality records, including:
* SOPs
* User Requirements Specifications (URS)
* Impact and risk assessments
* Test plans and test scripts
* Change controls
* CAPAs
* Ensure continued compliance with applicable regulations, guidelines, and internal quality standards.
Project & Engineering Support
* Participate in cross-functional engineering teams for the introduction of new or upgraded systems and processes.
* Provide guidance and support in preparing qualification activities.
* Safeguard cGMP compliance throughout project execution.
Deviation & Quality Management
* Address and follow up on deviations occurring during qualification activities.
* Support investigation and resolution processes to maintain compliance standards.
Stakeholder Communication
* Communicate quality, compliance, and planning status updates to QA Qualification team members.
* Collaborate effectively with cross-functional teams across departments.
Candidate Profile
Knowledge & Experience
* Experience in the chemical and/or pharmaceutical industry, specifically in equipment qualification.
* Strong knowledge of cGMP regulations and industry guidelines.
* Ability to translate complex technical information into clear communication suitable for all organizational levels.
* Sound judgement in assessing urgency, criticality, and impact of decisions.
* Ability to manage multiple projects simultaneously.
* Comfortable working independently as well as within cross-functional teams.
* Strong communication and interpersonal skills.
Technical Expertise
* Experience with manufacturing systems in pharmaceutical or chemical environments.
* Familiarity with:
* Problem reporting and change request systems (e.g., TrackWise, Comet)
* Document Management Systems (e.g., TruVault)
* Qualification and test management tools (e.g., Kneat)
Languages
* Fluent in English and Dutch (written and spoken)
Assignment Details
* Start Date: 23 February 2026
* End Date: 31 December 2026
* Business Unit: Pharmaceutical Quality Control (non-IT)
* Location: Geel, Belgium
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