Qualified Person
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Qualified Person - regio Antwerpen
The role
As a Qualified Person, you will make sure every product meets regulatory and quality requirements before it reaches the market. You will verify and certify batch release, ensure compliance with Good Manufacturing Practice (GMP), and liaise with regulatory authorities.
Key responsibilities
- Review and approve manufacturing and quality control batch records before product release.
- Ensure products for distribution meet the required specifications and safety regulations.
- Stay up to date with EU and international medical device and pharmaceutical regulations, including MDR, GMP and ISO standards.
- Work with Quality Assurance, Manufacturing, Regulatory Affairs and R&D to uphold quality and compliance.
- Conduct periodic product quality reviews. Investigate deviations, non-conformances and complaints, and implement corrective actions.
- Manage documentation and audits related to product release and regulatory inspections.
- Support continuous improvement of quality management systems and processes.
About you
- Proven experience as a Qualified Person in the medical device or pharmaceutical industry.
- Strong knowledge of European regulatory frameworks (MDR, GMP and related guidelines).
- Degree in Pharmacy, Chemistry, Life Sciences or a related field. Advanced certifications are preferred.
- Excellent analytical and decision-making skills, and strong attention to detail.
- Strong problem-solving and root cause analysis skills.
- Experience in batch release, quality control, quality assurance and risk management.
- Experience managing documentation and audits.
- Proficiency with QMS software and tools.
- Fluent English. Other languages are an advantage.
- A collaborative approach in a multidisciplinary team, with good stakeholder management.
If you are interested in discussing this exciting opportunity, apply here or via the NonStop Consulting website, or send it to me, Avetik Safaryan, on my LinkedIn. You can also always send your CV directly to my email, and I will contact you.
If you are not interested at the moment, you might know someone who is? Feel free to share it and help people in your network.
We are more than a standard recruitment agency. We go beyond expectations, work non-stop to find the right solutions for the right people, and are committed to meeting the expectations of all our clients.
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