devices packaging qc specialist - 10264.

The team takes care of packaging & device control and part of visual inspection

• Packaging control –verification of everything which is primary and secondary
• Device control – testing everything which enters under device, which includes securities syringes, auto injectors, as well as testing the functionality of this type of devices (finished products)
• Patient complaints on these devices
• Visual inspection (created recently, 5-6 months ago)– inspection by the production (particles confirmed by the QC; the investigation is done on the different particles in order to reduce the impact on the site)
• All the new products which come on site – new tests have to be created, check before validation if there is equipment or if there are any changes of the equipment; follow up of equipment, in contact with different suppliers, discussion of equipment purchases, preparation of projects with URS and other documents; qualification and validation (internally); the release of equipment; if there are methods to transfer – the follow up of the validation and the transfer of methods
• Follow up of change control
• The only commercial department to perform these tests of functionalities with the development team who develop the products.

Task / Daily activities:

• Facilitate the analytical transfer of the new products to the QC
• Participate in the validation of methods
• Participate in the creation of development & commercial specification with the different stakeholders
• Act as a project leader for the installation and qualification of new lab equipment.
• Coordinate all studies requested by the stakeholders, ensure the follow-up and communicate the results
• To support product
• To provide support to the management team of Visual inspection, Devices & Packaging lab
• Handle actions, deviations and realize investigations within the laboratory

Competencies

• Hard skills: Expertise in analytical transfer of methods (practical experience in implementation of methods in QC)
• Soft skills: Assertive communication (difficult stakeholders)
• Years of experience in the position / total: 3-8 years
• Expertise in analytical transfer of methods (practical experience in implementation of methods in QC)
• Expertise in the pharmaceutical analysis of, preferably, devices or packaging testing + Experience in GMP
• English + French (oral and written)

Consultancy :

We offer an attractive salary with extra-legal advantages: 

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car 
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc.

A rate as freelance is also possible