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 Challenge + Position
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) and measuring methods. He/she is foremost a problem solver based on robust root cause analysis (RCA), 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.
Generate protocols, methods and reports and support with or conduct Out Of Spec & Out Of Trend investigations. Review failure reports for out of specification (OOS) test results and write problem analysis and corrective action report (Deviation/CAPA).
Execute Root Cause Analyses in case of Out Of Specification (OOS) results.
Execute trend analyses and always be focused on continuous improvement.
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
Work to resolve and/or prevent technical or procedural issues and troubleshoot results and perform root cause analysis.
Align with other departments such as Operations and R&D
Work proactively, be resourceful and independent and a good team player
MSc in Analytical Chemistry or equivalent, in combination with 3-5 years of experience in a pharma or food industry.
Knowledge, Skills, Abilities
Broad analytical interest and profound knowledge of analytical chemistry and measuring methods.
Pragmatic problem solver, in a GMP environment.
Statistically sophisticated and able to execute and interpret trending.
Profound knowledge of IQ OQ PQ DQ in pharma.
Excellent reporting capability and organizational skills.
Good communicating skills (in writing and verbal) in Dutch and English.