Quality Lab Leader
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Luik Belgium.
The company is expanding its production capacity and is therefore looking for an expert to guide the operationalization process.
ROLE DESCRIPTION
The quality lab leader will coordinate the team of QC technicians in the chemical laboratory and organize the daily workflow of sampling and handling analytical samples. In addition, you will be responsible for the IQ, OQ, PQ of the site and select suppliers for the purchase of equipment in wet-chemistry and chromatography.
RESPONSIBILITIES
- Coordinate the successful transfer, validation and/or verification of analytical methods
- Assure compliancy of analytical activities in accordance with GMP and company SOPs
- Manage the follow-up of routine lab activities and control quality and safety standards of test results
- Manage SOPs, change controls, deviation, CAPAs and root cause analysis
- Organize stabilities studies (planning, protocols, deviations)
- Write, review and optimize the quality documentation system
- Coach the lab team and organize trainings
REQUIREMENTS
- Master in Pharmaceutical Sciences or Chemistry (PhD is an asset) with 5 years relevant experience in a strict GMP environment
- strong knowledge of GMP and GLP regulations, ICH guidelines, European pharmacopeia
- hands-on expertise in analytical chemistry, chromatography systems and statistical tools
- knowledge of Empower software
- excellent knowledge of French and English both oral and written
- autonomous, flexible and strong communication skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Alexander Wielemaker.
