QC Documentation Specialist (Analytical Chemistry)
PolyVation is a highly innovative company that develops and manufactures polymers customized for revolutionary technologies in the pharmaceutical and medical device industry. With our commercial partners, being a combination of start-ups, scale-ups and world-leading companies, we create the medicine of the future.
We now have an exciting opportunity to join our team, as we are looking for an experienced QC Documentation Specialist in the analysis and characterization of polymers, intermediates and starting materials. Our QC lab has a range of chromatographic equipment (GPC, GC, HPLC) and specific equipment used for characterization of polymeric systems (DSC, TGA, rheometry, IV, FTIR).
You will become responsible for 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 and/or pharmaceutical products.
You will work closely together with the entire QC team, and with colleagues from Manufacturing and Quality Assurance departments.
Responsibilities
- Write and review deviations, OOS investigations CAPA’s and change requests;
- Write and review analysis instructions, work instructions and operation instructions;
- Write and review documentation for method transfer, equipment performance, trending
- Support QC colleagues in writing;
- Establish document requirements jointly with QC and QA colleagues.
Requirements
- MSc or BSc degree in chemistry, analytical sciences or pharmaceutical sciences preferably with at least 3 years of experience in the industry;
- Excellent writing skills;
- Knowledge of GPC, GC and NMR
- 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.
- In case of non EU citizen: in possession of a work permit
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 (minimal 80%). 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. Kees Ensing (Manager QC) with reference to 'QCDS 2412 to info@polyvation.com. The deadline is December 31th 2024. For more information you may contact Kees Ensing via via +31 50 3680777 or info@polyvation.com.