Analyst 3 - Quality Assurance

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