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Quality assurance & validation specialist

Roulers
Vivid Resourcing
Publiée le Publiée il y a 12 h
Description de l'offre

Location: Ghent, Belgium

Company: Global leader in production for biomedical, pharmaceutical, food, and technical industries

Salary: Up to €7,000 + Premium Belgium Package


My client are seeking a Quality Assurance & Validation Specialist to help ensure that all biomedical products are manufactured, packaged, stored, and distributed in full compliance with current Good Manufacturing Practices (cGMPs).


You’ll join a collaborative team and report to the Quality and Compliance Manager Biomedical to uphold quality and drive improvements across our operations.


AREA OF RESPONSIBILITY AND RELATED TASKS:


• Quality Assurance

· Disposition of finished product batches & preparation of certificates of analysis

· Incoming release of materials and packaging components

· Investigation and resolution of non-conformances, deviations, and complaints

· Approval of change controls and supplier qualifications

· Management of specifications, QMS documentation and training program

· Performing internal audits

· Support during customer and authority audits, including CAPA follow-up

· Documentation support towards customers


• Validation

· Development of validation masterplans, protocols (IQ/OQ/PQ) and related documentation

· Execution of validation tests and coordination with external partners

· Oversight of process validation activities and QC results

· Ownership of re-qualifications and centralized validation archive

· Contribution to risk assessments (FMEA)


PROFILE

· 2+ years of experience in the (bio)pharmaceutical industry with working knowledge of GMP (EU & US)

· Skilled in root cause analysis and structured problem-solving

· Strong communicator with the ability to influence and collaborate across teams

· Proficient in Dutch and English

Organized, detail-oriented, and proactive


WE OFFER THE OPPORTUNITY AND CHALLENGE


· Impact: Your expertise will directly shape product quality and validation, fueling innovation in life sciences.

· Growth in a Global Leader: Be part of an international organization recognized for its pioneering role for biomedical applications.

· Learning That Lasts: Expand your skill set in GMP compliance, Quality Management Systems and validation technologies in a supportive environment.


If the role sounds interesting and you feel you have the necessary experience please do get in touch with me:

trishan.patel@vividresourcing.com

033180074

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