Description
One of our clients, an international company in the pharmaceutical industry currently requires a QC Analyst
Start: ASAP
Length: min 3 months, max 12 months
Location: South of Brussels
Mission Description:
The mission consists in operational and analytical support to the Biologics Pilot Plant, during the transition between start-up and 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 relateddocuments (sampling plans, batch records, check-lists, etc.)
Mission responsibilities:
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 processand 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 lab (reagent ordering, etc)
Specific professional/technical expertise and key skills required:
* The post holder should have technical knowledge of protein structure and function, and the analytical techniques required to study them. Experience in the operation of, and the analysis with the following analytical equipment: ELISA, electrophoresis, qPCR, microscopy, HPLC, spectrophotometer, pH-meter, conductivity-meter, osmometer.
* Ability to author comprehensive summary.
* Strong laboratory skills and a track record of spending >75% ofcurrent and past work function in the laboratory.
* Ability to multi-task and to organize and communicate large amounts of data.
* Good Interpersonal skills to communicate and maintain good working.
* Ability to work under pressure in a team environment under deadlines.
* Ability to work in a global Matrix and service-oriented environment.
* Good knowledge of French with notions of English
Reason Request:
New mission for 2014 to support the small team of two people in place for InProcess Controls, on day to day operations and implementation of improvements, as follow-up of lessons learned from first manufacturing campaigns, during transition from Start-up to routine operations for the BioPilotPlant.
Tags: QC, analytical, troubleshoot, analysis, tests, batch, GMP