Location | Beerse, Belgium |
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Business Sector | Pharmaceutical |
Contact email | |
Job ref | 25928 |
Published | about 2 hours ago |
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 f.chauca@panda-int.com