Location & department
Within Patheon, part of Thermo Fisher Scientific in Tilburg, we are responsible for the development and production of commercial medicines in dosed forms (soft-gel capsules).
You can think of products such as paracetamol, ibuprofen, but also various supplements. The soft-gel capsules are available at pharmacies and drug stores but also on a doctor's prescription. Because everyone contributes to the development and production of our soft-gel capsules, we are all responsible to make the world healthier, cleaner and safer.
The Lab Services Section is part of the Quality Control Department and ensures customer projects delivering results on time. Specifically, the Lab Services Section supports QC with equipment qualification, troubleshooting, investigations, documentation, and operational activities. The Section is also responsible for the Stability program.
The Quality Control Scientist has a broad analytical interest and profound knowledge of relevant analytical techniques (e.g. HPLC, GC, UV-Vis, IR, titration) and measuring methods. You are foremost a problem solver based on robust root cause analysis, pragmatically combining different types of information in a GMP environment. You like working in a fast-paced environment, where you keep you internal and external customers at all stages satisfied and up to date. You will be reporting to the QC Supervisor Lab Services.
What will you do
Support the QC Department specifically with troubleshooting and investigations.
Conduct or support with Out of Specification & Out of Trend investigations. Review failure reports for Out of Specification test results and write problem analysis and corrective action report (Deviation/CAPA).
Execute Root Cause Analysis in case of Out of Specification results.
Resolve and/or prevent technical or procedural issues and troubleshoot results and perform Root Cause Analysis.
Perform routine stability analyses.
Execute trend analyses and always be focused on continuous improvement.
Generate protocols, methods and reports.
Keep up to date with current regulatory requirements/guidelines on (ICH/FDA), GLP/GMP, pharmacopeia requirements (EP/USP) with respect to Quality Control and stability studies.
Align with other departments such as Operations and R&D.
Work proactively, be resourceful and independent and a good team player.
Bachelor’s degree in Analytical Chemistry (or related) in combination with 3-5 years of experience in a pharma or food industry.
Broad analytical interest and profound knowledge of analytical chemistry and measuring methods.
Pragmatic problem solver in a GMP environment.
Knowledge of statistics and able to execute and interpret trending.
Knowledge of IQ OQ PQ DQ in pharma.
Excellent reporting capability and organizational skills.
Good communicating skills (in writing and verbal) in English at basic knowledge of Dutch.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.