QC Documentation Specialist
PolyVation is looking for an experienced QC Documentation Specialist to strengthen our team in the analysis and characterization of polymers, intermediates and starting materials. You will be responsible for compiling the required documentation to support batch release and to support analytical method development & method validation. In addition, you will contribute to maintaining and improving the Quality Management System for QC related topics. The documentation must comply with the relevant internal and international standards for medical devices or pharmaceutical products.
You will work closely together with the entire QC team, as well as in particular with the Manufacturing and Quality Assurance departments.
Our QC lab is well-equipped with chromatographic equipment (GPC, GC, HPLC) and multiple other techniques suitable for characterization of polymeric systems (DSC, TGA, rheometry, IV, FTIR, and more).
Responsibilities
- Write and review change requests, deviations, OOS investigations and analysis instructions (SOP's);
- Write and review method development reports, project plans, validation protocols and reports;
- Support in writing CAPA's and instructions;
- Interact with the QC and QA experts for adequate interpretation of the requirements of the documentation to be written.
Requirements
- MSc or BSc degree in chemistry, analytical sciences or pharmaceutical sciences with at least 3 years of experience in the industry;
- Excellent writing skills;
- Familiar with GLP/GMP or similar guidelines;
- Familiar with (polymer) chemistry, analytical chemistry and/or pharmaceutical chemistry;
- Good communication skills and ability to work within an interdisciplinary team;
- Fluent in English is required (written and spoken), understanding and speaking Dutch is a pro.
What we offer
PolyVation offers a diversified and challenging position with lots of possibilities for self-fulfillment and growth within in a great working environment. Part-time could be workable if you prefer. Also a good balance between being on-site and working from home is very well possible for this job.
Send your application letter and resumé (CV) in English in attention to dr. Jaap Klijn (Manager QC) with reference to 'QCDS 0823' via the e-mail link you find on our website (info@). The deadline is October 1st 2023. For more information you may contact dr. Jaap Klijn also via phone or e-mail.