Introduction
Our partner is a fast-growing technological company developping, manufacturing and selling automated equipment and devices for the pharmaceutical industry.
Our partner is looking for a Quality Product Specialist to re-enforce its quality team.
Key responsibilities
The mission of the Quality Product Specialist is to participate to the GMP quality of the single-use devices commercialized by the company (most of them are product-contact), in close cooperation with the suppliers and subcontractors on the one hand, and the clients and users on the other hand.
- To audit, qualify and follow-up suppliers and subcontractors for devices, in cooperation with the other departments concerned;
- To assist audits by clients when required;
- To investigate non-conformities, generate and manage CAPA’s with clients, suppliers and subcontractors, as well as the documentation relative to non-conformities, claims, remarks and deviations about devices and associated processes;
- To participate actively to the change control process;
- In collaboration with the Dept. in charge of device manufacturing and the validation engineers, to ensure the quality follow-up of investment projects for capacity increase at subcontractor’s sites.
Other responsibilities
- To assist the commercial team and other colleagues by providing them with the necessary support for technical, scientific and regulatory matters relating to the devices;
Profile
- Master Degree in engineering, bio-engineering or science.
- Excellent investigation skills and attention to details
- Rigorous and autonomous
- Easy communication (verbal and in writing) with English speaking suppliers and clients,
- Ability to generate reports in correct English language
Experience
- At least three years of experience in a similar position in the pharmaceutical sector
- Added values (not mandatory):
- Experience with polymers;
- Experience with single-use systems.
Offer
- Innovative company
- SME spirit
- International environment
- Good working atmosphere
- Friendly colleagues
- Possibilities of internal evolution
- Attractive salary package