Quality Assurance (QRP Belgium) Senior Specialist

at  Organon

For our In-Market Quality Team in Belgium-Luxemburg, we are looking for a Quality Assurance Senior Specialist. The role must be based in Belgium or in the Netherlands.

REQUIRED EDUCATION, EXPERIENCE, AND SKILLS:

• Higher education (e.g. Master’s degree) in pharmaceutical, chemical or biological sciences
• Minimum of 3 years’ experience in Quality within Pharma industry;
• Knowledge and experience of GDP (and preferably GMP), Swiss pharmaceutical and Medical Devices regulations, as well as of EU and other international guidelines
• In-depth knowledge of Quality Management System processes
• Experience in applications such as SAP, eQMS solutions and eLearning systems is a plus
• Good Communication, interpersonal skills and fostering cross-functional collaboration.
• Problem solving and decision-making capabilities, able to apply risk management.
• Fluent in English and in French and/or Dutch.

WHO WE ARE:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

ABOUT THE ROLE:

In this role the Senior Specialist QA will act as QRP, reporting to the Cluster lead ME-PEI. The QRP is responsible for direct supervision of the operation, safety, efficacy, and quality of the medicinal products, and to ensure that wholesale of ready-to-use medicinal products are performed in accordance with the rules of Good Distribution Practice (GDP).

ROLE RESPONSIBILITIES:

• Develop, implement, and maintain the local Quality Management Systems (procedures)
• Ensure Quality training of personnel including assessment of training effectiveness
• Approve and review local procedures with Quality impact
• Ensure effective management of Product Quality Complaints (PQCs) including routing the PQCs and samples to the manufacturing site, and trending.
• Handling of suspect Counterfeit, Diversion or Tampering (CDT) including HA notifications
• Ensure compliant handling of Physicians Samples (e.g. distribution, storage and tracking)
• Local coordination and execution of recalls
• Management of repackaging/re-stickering activities of doctor samples in coordination with regional and global Quality Organization
• Decide on the final disposition of returned, rejected, recalled or falsified products independent from commercial functions
• Management and review of Product Quality Reviews (PQRs)
• Deviation management, overview, tracking and trending
• Management of CAPAs, including tracking
• Ensure handling of temperature excursions during transport, warehousing, and distribution
• Ensure Change Control procedure is applied
• Oversight of validated IT-systems used in the local GxP area.
• Ensure customers and suppliers have the appropriate HA authorization to manufacture, warehouse, distribute, or purchase medicinal products
• Review and approve Quality Agreements to ensure inclusion of appropriate Quality elements
• Quality oversight of subcontractors and Third-Party Logistics provider (3PL) to ensure operations (e.g. incoming inspection of Organon products, storage, picking and distribution) complies with regulatory requirements and the conditions specified in the Dossier
• Conformity check of medical devices according to MedDO