Operations Project Investigation Expert
4 maanden geleden
Amsterdam | Belgium | Operations Project Investigation Expert | Cell culture | GMP | CAPAs | Risk assessment |
**Your new company**
Our client, in Belgium, is a global biotechnology company dedicated to treating and curing life-threatening diseases. They develop cell therapies across a diverse range of technology platforms, including autologous and allogenic chimeric antigen receptor T - cell and NK cell - based immunotherapy. They are committed to improving the lives of patients worldwide at multiple sites and their goal is to reimagine healthcare and to deliver transformative treatments in the fields of oncology and cell therapy.
**Your new role**
We are searching for a passionate Operations Project Investigation Expert to join our client in Belgium. In this role you will conduct thorough investigations to identify and resolve issues in our manufacturing processes caused by human error. Your efforts will be crucial in ensuring the safety and timely release of our products.
As an Operations Project Investigation Expert, your responsibilities will include:
- Performing in-depth investigations to swiftly identify and resolve incidents caused by human error in the production process, ensuring safe and timely product releases.
- Implementing robust investigation methods and training the team to handle quality investigations efficiently.
- Acting as the primary contact for regulatory agencies during inspections, confidently defending investigation strategies and reports.
- Maintaining and leading the research dashboard, support QEM systems, and implementing process improvements based on lessons learnt.
- Fostering lasting relationships with various stakeholders to ensure smooth handling of investigations
**What you'll need to succeed**
- At least 3 years of project execution experience in an operational cGMP or ATMP environment within the biotech or pharmaceutical industry.
- Knowledge of cGMP regulations and FDA/EU guidelines related to ATMPs, and experience with risk assessment and root cause analysis
- Previous experience in manufacturing, quality, or engineering is essential.
- You are fluent in Dutch or English, with strong oral and written communication skills.
- You are an enthusiastic team player, eager to learn and solve complex technical and scientific challenges.
- You are flexible, problem-solving and can multitask well, and you have a strong desire to learn and grow.
**What you'll get in return**
**What you need to do now**
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