Description
JOB TITLE: Manager Filling operations DEPT: TRD- SECONDARYREPORTS TO: Manager Manufacturing
FUNCTION DESCRIPTION (copy definition in TP book)
TRD : Technical Research Development
Core activities of Secondary Manufacturing
Transfer, scale-up & manufacturability of new vaccines
Supply clinical lots for each clinical study
Phase 3: for primary
Pase 1, 2 & 3: for secondary
Lead specification settings for consistency lots
As Filling Manager, you will be responsible for the Secondary operations (Filling - Freeze-Dried process- Visual inspection) within TRD organisation through these activities:
operational activities
o Responsible for activities and resources engaged in the production process and for their continuous optimization.
o Manage day-to day activities (Filling of syringes/liquid vials/freeze-dried vials ; including visual inspection and leak testing machine)
o Manage and coordinate deviations and change controls related to the filling operations.
o Ensure that the facility, equipment, and staff are appropriately designed and trained to ensure production activities of new products for clinical trials purpose.
o Monitors clinical production quality and efficiency through key performance indicators
o Ensures proper functioning and validation of manufacturing equipment.
o Ensures the operational back-up activities of the Logistic Filling Manager during his holidays.
People Management
o Support the Management to optimise the team of +/- 15 people (technicians and operators)
o Co-ordinates manpower targets, resources and skills.
Supply demand and planning :
o Evaluates capacities (employees) necessary to the completion of the production plan
o be involved in the coordination of supply and demand.
Quality Management :
o Supports to internal and external audits
o is responsible for the quality of clinical Filling operations
o is responsible for the compliance of operations with cGMP's and Authority requirements.
o Supports File submission.
We offer you diversified and a challenging mission.
Profil :
Scientific Master or equivalent experience
As the ideal candidate for this mission, you have a very good knowledge of Filling operations and a broad understanding of secondary operations.
You have a very good team spirit and your People Management talent is well established.
You have a good stress resistance.
An experience in Audit preparation and in English is an asset
Very good level of written and spoken French.