- Working with Quality Control (QC) methods and instruments, good understanding of CAPA, Deviation, Change Control and regulatory guidelines (Including ICH)
- Analytical Method Validation
- Hands-on working on chromatographic Assays like HPLC/UPLC, Spectroscopic Assays (UV spectroscopic), Electrophoresis (Capillary Electrophoresis), ELISA, molecular assays like PCR, Q-PCR, ddPCR, sequencing.
- Technical writing, including report/protocol, risk assessments. Including advise on and ensure generation, review and approval of QC documents in coordination with other departments and in accordance with cGMP
- Subject matter expert and contact person within QC department for method and equipment related subjects.
- Proactive follow-up on development activities within the applicable discipline as well building up and sharing of knowledge within the QC department and functioning as a coach and trainer.
- Perform other duties with respect to the field of QC as assigned by QC management
- BSc/MSc in chemistry/biotechnology
- At least 7-10 years of relevant working experience
- Proven experience on chromatographic Assays like HPLC/UPLC, Spectroscopic Assays (UV spectroscopic), Electrophoresis (Capillary Electrophoresis), ELISA, molecular assays like PCR, Q-PCR, ddPCR, sequencing.
- Experience with GMP
- Strong planning, and scheduling skills
- Organized
- Strong ability to interpret data and troubleshoot testing in area of expertise.
- Excellent ability to problem solve.
- Changes work within their group quickly in unexpected situations.
- Outstanding ability to collaborate with other departments
- English language skills (verbal & written)
- Dutch working permit
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QC Technical Expert - Geleen, Nederland - Lonza
Beschrijving
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
The Quality Control Expert implements and executes activities in the Quality Control department in the broadest sense while ensuring compliance with all existing GMP and safety standards. Acting as a contact person in complex issue handling and complex activity performance which requires knowledge and skills in the applicable expertise branch.
The position needs to thoroughly understand the activities linked to the applicable expertise, risk analysis, method implementation and other QC related issues in his/her branch
The technical Expert Cell Therapy will generate, review and approve QC documents and acts as expert for QC during internal and external audits and inspections.
Key responsibilities:
Key requirements:
If you're a proactive, enthusiastic and organized person who'd like to hear more about this fantastic role, get in touch.
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Reference: R59902
