CDI / Permanent
Competitive salary and package
We are working with a multinational client with decades of market experience in supplying pharmaceutical and biotech companies with small to commercial scale cGMP peptide API manufacturing, using world-class production processes.
They are working on innovative technologies with the objective being to shorten synthetic processes / reduce step number and control quality. They are hiring for a Quality Control Manager to lead a team of 12 scientists.
What you’ll do:
You will be responsible for the smooth running of the laboratory, on-time results, GMP (Good Manufacturing Practice) compliance and the management of the 12 chemistry and microbiology team members. This will involve managing SOP’s, change controls, deviations, OOS (Out Of Spec), CAPA (Control and Preventative Actions).
You will develop and review documentation for the department, including test methods, SOP’s protocols and other activities that ensure compliance with GMP.
You will validate analytical methods, and be writing up validation protocols, analysing validation results and providing conclusions, before releasing the validation report.
- Stability Studies
- Review and approval of analytical dossier
- Contact with external customers for QC release
- Technical support during customer audit FDA (Food and Drug Administration), AFMPS (The Federal Agency for Medicines and Health Products of Belgium)
- Coordinate lab equipment acquisition, qualification, calibration and preventative maintenance
- QC Optimisation Processes
We are seeking a University degree in chemistry (or related), with an analytical background. You must be fluent in written and spoken English and French. Please correspond with your application in English.
You will have specific competencies in:
- Strong laboratory skills and good knowledge of analytical chemistry
- Very good knowledge of cGMP in a regulated environment (US and Eur)
- People management experience (Leadership experience)
- Strong problems solving skills, issue resolution and root cause analysis
- Experience with guidelines , standards (ICH, Pharmacopea, 21CFR part 11)
- Experience with regulatory inspection (FDA and AFMPS)
- Proven ability in prioritizing according to the needs
- 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.