QC Supervisor LES (Laboratory Execution System) - Temporary Contract
The LES (Laboratory Execution System) QC Biology (Microbiology & Virology) supervisor contributes to implementation of LES activities through different teams of his / her Department.
He / her guarantees implementation according to defined rules and to the program Roadmap.
To guarantee that implementation will be compliant (in alignment with QA partner) the role ensures the following :
Managing change (process, mindset, within the QC Biology Teams is a key success factor.
Being a QC Biology representative for sharing / explaining QC Biology specificities to LES Implementation team
Being an active member for key delivery process steps : Data collections, prototyping, Workbook validation (DCMA) and implementation activities (BCO)
You will be responsible to :
Support current QC Biology Supervisors and operators in delivering LES program / planning within QC Biology
Act as key player during the project roll-out (Data collection, Prototypes, DCMA ( validation) and lab readiness (BCO).
These activities will be executed according to LES processes (training will be provided by LES program Team) and laboratories priorities / planning adjustements
Be a strong partner to laboratory and LES Implementation manager to build roll-out plan (time-line, WoW, team sizing, ) taken into account QC Biology Lab constraints.
According to LES Roadmap program discussed with teams and defined by LES Implementation managers, drives the roll out of the LES project through the different teams of his / her Department
According to current guidance established by LES LSPOC (Documentation, training, archiving, change control, ) of the concerned process, implement the paperless project within his / her Department.
Escalade risks & problems, proposing action plans to LES Implementation Manager
With help of quality systems LSPOC’s, implement the change according to compliant process.
Be a good team player
Knowledge of basic microbiology testing in pharma industry is a plus, as well as digitalization competencies
According to implementation plan and needs, support to other core business of QC Biology might be considered (Deviation management, change control not LES related)
Basic Qualifications :
We are looking for professionals with these required skills to achieve our goals :
Master Degree in Sciences
Sciences with quality orientation
Experience in analytics (experience in virology, bacteriology is a plus)
Position requires ability to understand business process management, and networking across the upper QC (Biology & Raw Materials) organization
Good knowledge of Quality Process (Testing, Documentation, training, archiving, change control)
Min. 3 years of relevant experience in a quality QC department
Deep Knowledge of cGMP (potentially Audit fronter)
Experience in team management / stakeholder management 5-20 people
French & English skills
Preferred Qualifications :
If you have the following characteristics it would be a plus :
Experience in change management
Ideally, has already participated to Lean initiatives, LIMS is a plus
Innovative thinking, open to change
Ability to use IT tools