Technicien Contrôle Qualité

Our client, a pharmaceutical company located in Belgium, is looking for a QC ANALYST to support the quality control activities related to the drug manufacturing process. The QC TECHNICIAN will work at our client in Belgium for at least 6 months.

Scope of work:

The Plant is manufacturing biological Drug Substance for human use, and is a multiproduct facility, with several different products/manufacturing campaigns per year.

The mission consists of operational and analytical support to the Plant for routine operations, with special focus on, but not limited to, analytical support to the In-Process Controls team as well as supporting the implementation of improvements to SOPs and process related documents (sampling plans, batch records, check-lists, et.al.)

The mission includes primarily, but is not limited to, the following responsibilities:

- Routinely perform analytical testing of IPCs, to ensure a timely monitoring of the GMP and non-GMP process as well as various GMP and non-GMP process samples for understanding of the manufacturing process and relevant product quality attributes
- Troubleshoot and solve analytical issues on the techniques run in the laboratory.
- Prepare documentation (procedures, protocols, reports, sampling plans, batch records)
- Be involved in the transfer of analytical methods from other laboratories
- Demonstrate ability to analyse data, with good attention to detail
- Have an excellent record keeping and documentation
- Openly exchange results, observations, and possible improvements
- Present/discuss results in project team meetings
- Contribute in the implementation of new technologies where appropriate.
- Train process operators in performing simple in process analytical procedures on the production floor
- Follow the procedures in place as well as the HSE rules in the laboratory
- Work according the agreed timelines
- Highlight any atypical result or out of specification results according to the established procedures
- Ensure the maintenance and qualification of some analytical equipment
- Contribute the logistics in the laboratory (reagent ordering, etc)

Requirements:

- Mandatory: at least 2 years spent in a GMP biological analytical laboratory
- Mandatory: use of the software Empower or other CDS software (chemstation, EZ Chrom)
- Mandatory: experience in the operation of the following analytical assays: concentration by affinity chromatography, charge variants, size variants
- Mandatory: ability to communicate effectively with good French and English skills, as the post holder will be liaising with colleagues from international sites
- Technical knowledge of protein structure and function, and the analytical techniques required to study them.
- Strong laboratory skills and a track record of spending >75% of current and past work function in the laboratory.
- Ability to multi-task and to organize and communicate large amounts of data.
- Ability to work under pressure in a team environment under deadlines.

Keywords:
QC, CONTRÔLE QUALITÉ, CONTROLE QUALITÉ, QUALITY CONTROL, ANALYTICAL CHEMISTRY, CHIMIE, TECHNICIEN QC, TECHNICIEN CONTROLE QUALTIÉ, TECHNICIEN CONTRÔLE QUALITÉ, TECHNICIEN DE LABORATOIRE, LABORATORY TECHNICIAN