Quality Engineer Beerse (BE) • Panda International

QA Qualification/Validation 
Geel, Belgium – Contract

Company Description
This leading global healthcare organization is dedicated to advancing innovative medicines and therapies that improve patient lives. The Geel site plays a critical role in manufacturing and quality operations, ensuring regulatory compliance and excellence across the entire product lifecycle.

Job Description
As a QA Qualification/Validation Contractor, you will support the QA Engineering department in ensuring that all qualification and validation activities meet regulatory, procedural, and compliance requirements throughout the full system lifecycle – from concept and project phases to operational use and retirement.

Depending on your expertise, you will be matched to one of several focus areas:

• Manufacturing Systems Qualification

• Laboratory Systems Qualification

• Facility and Utility Systems Qualification

• IT/Automation Systems Computer System Validation

In this role, you will provide quality oversight on validation deliverables, collaborate closely with engineering and cross-functional teams, and ensure compliance with cGMP standards during the introduction and upgrade of systems and processes.

Key Responsibilities

• Review and approve qualification/validation documentation, including SOPs, user requirements, risk assessments, test plans, test scripts, change controls, CAPAs, and related quality records.

• Collaborate with engineering and project teams to advise and support qualification/validation planning and execution, while safeguarding cGMP compliance.

• Investigate and follow up on deviations arising during qualification/validation activities.

• Provide clear communication of project and compliance status to QA Qualification/Validation team members.

• Contribute to continuous improvement initiatives within the QA Engineering function.

Essential Requirements

• Degree in Life Sciences, Engineering, or a related field.

• Professional experience in the pharmaceutical and/or chemical industry, with focus on qualification/validation.

• Strong knowledge of cGMP regulations, guidelines, and quality standards.

• Ability to interpret and “translate” technical information into clear communication across all levels of the organization.

• Strong decision-making skills, with the ability to assess urgency, criticality, and impact.

• Proven ability to multi-task and manage multiple projects simultaneously.

• Independent, proactive, and collaborative team player with excellent communication skills.

Technical Expertise

• Familiarity with systems in Manufacturing, Laboratory, Facility/Utility, IT, or Automation environments.

• Experience with problem report and change request systems (e.g., TrackWise, Comet).

• Knowledge of document management systems (e.g., TruVault).

• Exposure to test management tools (e.g., Kneat).

Languages

• Fluent in English and Dutch (written and spoken).

Additional Insights

• Location: Geel, Belgium

• Contract Type: Contractor (duration to be agreed)

• Start Date: ASAP

Interested?
Send your CV to via de button "Solliciteer nu" op deze pagina.