QA Compliance Expert
- Experience Level
- Experienced (non-manager)
QA Compliance Expert - Permanent French part of Switzerland
We have an interesting opportunity for a QA expert who is interested in further development in biotechnology therapies in particular in biologics . This role will support QA and compliance operation for manufacturing of biologics for clinical trials
Your daily tasks:
* Responsible for the review of facility validation studies, facility SOP and environmental monitoring
* Responsible for the monitoring of facility relates audit findings, deviations change control and CAPA
* Execute activities such as equipment /system validation to meet defined agreements
* Review and update Validation Master Plan, system/equipment qualification
* Optimise facility quality processes based on EU/FDA GMP requirements and guidelines.
* Draft facility quality assurance policies and procedures and update quality manual
* Perform trainings for other team members in the Quality field
* Provide support to preparation for audits and inspection
* Support KPI preparation and reporting
EDUCATION AND DESIRED EXPERIENCE:
* Bachelor's degree or equivalent in life sciences, engineering, biochemistry, biology pharmacy
* 5 Years of experience in GMP environment and hands 'on experience in quality
* Experience in cleanroom engineering, Manufacturing, Computer validation system and system Qualification.
* Experience in deviation and change control management including CAPA system.
* Excellent Interpersonal and communication skills
* Highly organized and ability to work both independently as well as part of a team
* Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a flexible and constructive manner
* Demonstrated skill in planning and organization, customer service, problem solving and proactivity
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.