EUMEDICA SA is an international reference actor in the pharmaceutical sector. We offer to pharmaceutical companies a wide range of custom-made services in various domains such as regulatory affairs, distribution and promotion of pharmaceutical products as well as tailored logistics services.

Based in Manage, we are looking for talented and dynamic profiles to complete our teams and accompany us in our development.

Qualified Person / Responsible Person (m/f):

Description of the function:

In this role of QP/RP, you will make sure we are adhering strictly to the Guidelines on Good Distribution Practice and Good Manufacturing Practice of Medicinal Products. Also you will apply the requirements of the customers and the quality policy of the company regarding the operations of secondary packaging, release, storage and distribution of medicinal products.

Your main responsibilities:

Batch Review and Release

• Manage the system of batch review and release
• Release products according to the procedure (QP confirmation and certification)
• Review and approve the deviation reports
• Verify the documents of conformity and the packaging of commercial products according to the procedure
• Verify the additional labeling according to the procedures for clinical trial supply
• Ensure the GMP certification of secondary packaging performed at Eumedica according to the current procedures
• In charge of the approval of master labels

GxP Authorization & Regulatory

• Ensure that the activities realized within Eumedica enter within the scope of the current authorization 860 (H, IMP) of Eumedica
• Maintain the regulatory authorizations of the site updated according to the activities performed at Eumedica
• Ensure a regulatory monitoring of GMP and GDP standards and regulations

Recall and Return Processes and Product Quality Review

• Ensure review and approval of PQRs
• Approve the product’s returns
• Responsible to launch and manage product recall process

External Quality

• Review and Approve the quality contracts with the customers and the suppliers (Quality Agreement)

Quality projects support

• Ensure review and approval on deviations, CAPAs and support teams in discussions concerning any GMP/ GDP events
• Member of the CC board to assess change request
• Involve in several processes/projects where the QP insight is required. Lead projects linked to Quality topics
• Participate to Quality Meetings (internal and external)
• Involve in Quality Management Review Process
• Manage and Support QU Unit during external audits or HA inspections on site and represent EUSA QP

Your profile:

• Must possess a Master Degree in Sciences preferably in Pharmaceutical Sciences to be in line with the local regulations for QP/RP
• 3- 5 years in the role of QP or RP within quality functions of pharmaceutical health care industry or within regulatory agencies
• Proficient in GMP and GDPs and requirements for pharmaceutical products distribution
• Demonstrated ability to develop and apply Eumedica procedures within Quality and Compliance areas and support company projects
• Ability to switch priorities and manage more than one project at time
• Strong negotiating skills and demonstrated ability to effectively communicate ideas, lead and accomplish challenging goals and objectives
• Good Verbal, written and presentation skills in English, to deal effectively with all levels of management
• Team oriented worker with excellent interpersonal skills
• Service oriented with ability to challenge and evaluate external and internal demands. “Make things happen” attitude.

Working place:

Operational site in Manage (near Nivelles, easy to reach by car).