In this pivotal role as Operational QA, you will delve into investigations to identify and resolve issues in the manufacturing process caused by human error. Your contributions will be crucial in ensuring the safety and timely release of our products. If you are passionate about quality and eager to make an impact in personalized medicine, this opportunity is for you!

RESPONSIBILITIES:

• Operational Investigations: Conduct thorough investigations to swiftly identify and address the root causes of incidents due to human error in the production process. Ensure safe and timely product releases by implementing robust investigation methods and training the team on quality investigations;


• Quality and Compliance: Ensure all investigations adhere to the highest GMP standards and regulatory requirements. Lead and report on deviations, support other departments in deviation investigations, and apply corrective and preventive actions (CAPAs);


• Regulatory Liaison: Serve as the primary contact for regulatory agencies during inspections, confidently defending investigation strategies and reports;


• Continuous Improvement: Maintain and lead the research dashboard, support QEM systems, and implement process improvements based on lessons learned;


• Stakeholder Collaboration: Build and maintain strong partnerships with various stakeholders to ensure smooth handling of investigations.

YOUR PROFILE:

• Education: Master’s degree in (bio)engineering, science, pharmacy, or a related field, or equivalent experience;


• Experience: Minimum of 3 years of project execution experience in an operational cGMP or ATMP environment within the biotech or pharmaceutical industry. Previous experience in manufacturing, quality, or engineering is essential;


• Languages: Proficiency in Dutch and English, with strong written and oral communication skills;


• Skills and Attributes: Enthusiastic team player, eager to learn and solve complex technical and scientific challenges. Excellent organizational, analytical, and scientific writing skills. Proactive, positive, and flexible attitude, with the ability to build strong partnerships;


• Expertise: Knowledge of cGMP regulations and FDA/EU guidelines related to ATMPs. Experience with risk assessment and root cause analysis.

ARE YOU INTERESTED TO APPLY:

Please click 'apply now' to forward an up-to-date copy of your CV, or email me directly : aurelie.defoin@hays.com.