QC Analytical Expert
Permanent / CDI role
€3500 to €4000 *14.42
We are working with a multinational pharmaceutical company in Brussels, Belgium who are seeking a QC Analytical Expert. Our clients expertise is in supplying pharmaceutical and biotech companies with small to commercial scale cGMP peptide API manufacturing using world-class cost-effective production processes.
What you’ll do:
The QC Analytical Expert will be working as part of the Quality Control department and provide technical expertise to the technicians and within the different projects.
Under the direction of the QC Manager, continuously strengthen analytical & technical awareness and investigate technical/analytical issues using applicable process improvement and problem solving techniques to ensure successful testing and projects outcomes.
The main activities will be:
- Manage and review analytical activities (internally or with external partners) for the different analytical methods of the different projects.
- Review experimental data or analytical documents (protocols, reports and/or analytical methods) in the frame of development, pre-qualification, qualification, validation and transfer of analytical methods (mainly HPLC/UPLC) within the QC department
- Participate in the troubleshooting for routine and stability analyses in collaboration with QC technicians
- Integrates cGMP requirements (deviation, investigation, non-conformities) in analytical activities
- Participates as analytical expert to regular teleconferences and meetings with customers and internal team meetings as appropriate
Your background and qualifications:
Several years experience in the pharmaceutical / biotechnology industry, API experience is an asset.
- University degree in a scientific discipline with analytical background is mandatory (Chemistry is an asset)
- Language requirements: English (written and spoken), French
- Strong laboratory skills and good knowledge of analytical chemistry
- Chromatographic expertise (HPLC, UPLC, GC, IC)
- Very good knowledge of cGMP in a regulated environment (US and Eur)
- Good problems solving skills, issue resolution and root cause analysis
- Experience with guidelines , standards (ICH, Pharmacopoeia, 21CFR part 11)
- Experience with regulatory inspection (FDA and AFMPS)
- Strong quality and service minded
- Customer oriented, team player, focused on improvement
- Excellent interpersonal skills
- Working knowledge of computer packages (Word, Excel, MS Project, Visio, Power Point)
- Able to work independently in a fast paced multitasking environment.
On this occasion, LiCa Scientific is acting as an employment agency