Description
For one of our clients in the pharmaceutical industry, we are currently looking for a Quality Assurance Engineer
Start: 2/5/13
Duration: 6 months
Location: South of Brussels
MISSION SUMMARY:
The candidate will be responsible for:
The execution & follow-up of the deviations & CAPAs from 2012and/or 2013 in accordance with the client's procedures for BatchRecord, Deviation & CAPAs Process us Management.
ESSENTIAL FUNCTIONS:
The position includes responsibility for all or part of the following steps:
* Management & Follow-up of Deviations/CAPAs on daily/weekly/monthly basis.
* Identification of Deviations/CAPAs priorities and complete them through the client's SAP System.
* Discussion with Managers/Supervisors/QA Representative to finetune solutions and deploy pragmatic actions (SOP updates, ).
* Track action plan from QC, Maintenance, Production to close out in time all Deviations.
* Fulfill/Complete CAPAs, Deviations, Batch Record to allow batch release for packaging.
* Update SOPs when necessary and get all required signatures.
* Training to Production or Maintenance Team, of updated SOPs according recommendations from CAPAs actions.
* Shop floor analysis, if necessary to complete troubleshooting &identify solutions.
PROFILE:
* An Engineer qualified in Chemical Engineering, Process Engineering, Biochemistry discipline
* Minimum 5 years experience in the pharmaceutical industry
* At least 2-3 years in the client's secondary activities(filling vials preferred),
* Experience of Batch Record Release Leadtime, Deviations/CAPAs process & management and cGMP requirements/Environmental Monitoring/Aseptic Best Practices.
* Rigorous in following documentation and the deviations & CAPAs stages in accordance to the client's policies & requirements
* Capable of working as part of a multidisciplined team as well as an individual.
* Good organizational skills and ability to manage their time and identify priorities: if necessary adapt schedule to fit with production shifts organization (6-14 or 14-22).
* An analytical, logical and practical person.
* Good reactivity when facing challenges such as changes in schedule.
* A working knowledge of written and oral French and English.