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Job Details
Your role:
QC Sampling activities:
Improve the standard time via continuous improvement projects and realization of the activities
To support and improve the interface with external labs (sample shipment & results handling)
To support the sampling team in some operational activities (sample reception, aliquoting, worklist corrections)
QC Compliance activities:
Lead the deviations related to our activities
Trainer for compliance and operational activities
Participation in the governance of the compliance community
General and Project Management :
To ensure adherence to the detailed planning by all stakeholders,
To ensure KPIs target are reached,
To ensure compliance during deployment and hyper-care phases,
To ensure final user's adherence,
To build detailed deployment and hyper-care planning,
To monitor activities progress
To lead and support project team for deployment activities,
To raise and follow CCP,
To build change management plan,
To react on and resolve all technical issues involving the group autonomously in a timely and positive manner,
Be an actor of the continuous improvement initiatives using a lean process mindset,
To strongly participate in the management of our performance meeting and contribute to improve it.
Your role:
QC Sampling activities:
Improve the standard time via continuous improvement projects and realization of the activities
To support and improve the interface with external labs (sample shipment & results handling)
To support the sampling team in some operational activities (sample reception, aliquoting, worklist corrections)
QC Compliance activities:
Lead the deviations related to our activities
Trainer for compliance and operational activities
Participation in the governance of the compliance community
General and Project Management :
To ensure adherence to the detailed planning by all stakeholders,
To ensure KPIs target are reached,
To ensure compliance during deployment and hyper-care phases,
To ensure final user's adherence,
To build detailed deployment and hyper-care planning,
To monitor activities progress
To lead and support project team for deployment activities,
To raise and follow CCP,
To build change management plan,
To react on and resolve all technical issues involving the group autonomously in a timely and positive manner,
Be an actor of the continuous improvement initiatives using a lean process mindset,
To strongly participate in the management of our performance meeting and contribute to improve it.
Qualifikationen
Who you are:
Eng. in sciences (chemistry, Biology.) or at least 1 year of experience in GMP environment
At least 1 year expertise in Biotech Industry
Experience in Quality Control and Quality systems
Experience in planification tools is a plus
Knowledge in RFID principle is a plus
Good knowledge in visual management
Knowledge of applicable cGMPs
Fluent in French & English
Process mindset with the appropriate level of customer service
Able to understand in detail all the activities carried out in the group and its role in the context of the overall site and QC processes
Able to react and resolve all human & technical issues involving the group autonomously in a timely and positive manner, with an efficient solution
User of the Problem-Solving tool and ensure its use in the group
Result driven and a 'can do' attitude, helping organization to deliver stretch goals on lead time
Autonomous and reliable, highly motivated
Customer oriented
Collaborative and positive communication within the team and with partners / customers
Seeking for proactive implementation of new technologies, new good practices and continuous improvement for the team
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I
Inès d´Aubigny
Randstad Merck Aubonne
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