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 Documentalist develops, manages, checks and keeps documents of the documentation system of the Quality Control department up to date, reporting to the QC Supervisor Lab Services.
You have some knowledge of working in a Quality Control department and you are familiar with analytical terminology. Besides that, you like working in a GMP environment.
What will you do?
- Be in the lead of drawing up and updating documents (such as SOP's, Work Instructions, Methods and Forms) for all Quality Control sections in accordance with applicable laws, regulations and global policies.
- Process documents in a document managing system and process changes in a quality management system.
- Coordinate with the Quality Control sections and Registration department to get inputs on the modifications.
- Responsible for archiving documents.
- Check Raw Materials specifications.
- Track changes of pharmacopoeias in relation to product specific methods and general methods.
- Responsible for the timely completion of new documents and updates.
- Completed education MLO/HLO (Analytical/Chemical), in combination with 3 years of experience in Quality Control in pharma or food industry.
Knowledge, Skills, Abilities
- An excellent working knowledge of oral and written English and Dutch.
- Good knowledge in MS tools and office.
- Proactivity and good overview skills. Eye for structure and detail.
- Ability to write, edit and review quality related documents.
- Experience in maintaining a GMP Document System.
To Apply, please click the following link: https://thermofisher.contacthr.com/82306142
Apply on company website