Founded in 1987, Corden Pharma Brussels was a member of the Solvay group until being acquired by CordenPharma in October 2013. Peptisyntha has built more than 30 years track record of success in supplying pharmaceutical and biotech companies with small to commercial scale cGMP peptide API manufacturing using world-class cost-effective production processes. Through expertise and capabilities in all synthetic manufacturing technologies, Peptisyntha assesses and customized their manufacturing approach to achieve the most effective manufacturing process for their customers.
Corden Pharma Brussels has developed a portfolio of innovative proprietary technologies with the objective to shorten synthetic processes / reduce the number of steps, control quality, and simplify (or eliminate) HPLC purifications for short peptides.
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.
- >> Manage and review analytical activities (within Corden Pharma Brussels 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 trouble-shooting 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
Minimum experience required:
- >> 5 years with 3 years in a similar role in the pharmaceutical industry (API 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
Specific competences required:
- >> 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.
Please refer to: QC Analytical Expert