Quality Assurance Officer - FTC - 12 months

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

Everything we do at KKI, is rooted in the idea of leaping forward to make people smile. We are committed to innovation, for the benefit of the patients who count on us to support them. From medicines for rare and underserved diseases, to the support families need when facing a life-changing diagnosis – our team is proud of all we deliver, but also humble in knowing how much more needs to be done. By listening to patient stories, we gain a better understanding of the obstacles patients and their families face – so we can work to better meet their unique needs. The real proof of our impact is in the smiles we see on patients’ faces, when we have helped answer a need, or improved their well-being through our work. While the journey is not easy, it is one that is filled with purpose.

Job Purpose:

An operational role to ensure GDP compliance in the BeNeLux territory for Kyowa Kirin Pharma B.V. (KKP bv) for the distribution, supply and marketing of pharmaceutical products in the BeNeLux, including narcotics.

Key Responsibilities:

Quality Assurance

• Actively contributes to activities under the responsibility of the GDP Responsible Person.
• Participate in the execution, monitoring and updating of the Quality Management System in line with local regulations and Group Policies & Procedures.
• Participate in the management and monitoring of Product Quality Complaints and Returns
• Participate in the development and execution of the internal and external audit plan, including management of associated action plans (CAPAs).
• Participate in the management of non-conformities, deviations and temperature excursions, including management of CAPAs.
• Participate in the qualification activities of suppliers and customers.
• Support in supervising the performances of the (outsourced) activities including the preparation of associated reports.
• Actively contributes to the local training program and to the traceability of related records for KKPbv and relevant Central Cluster employees.
• Preparation, update and review of relevant technical/quality agreements with any local supplier or contractor involved in GDP activities.
• Participate in the management of stock control, including handling of shortages and recalls.
• Contributes to continuous improvement within the organization through a risk management process.
• Work closely with the service providers in the territory.
• Work closely with relevant members of cross functional groups in Kyowa Kirin as appropriate (e.g. Project Management, Regulatory Affairs, Pharmacovigilance, Medical, Supply chain and Business)
• Advocate the KK quality culture.

Pharmacovigilance

• In the absence of the PV responsible person, may act as deputy for the initial receipt, local processing and archiving of Individual Case Safety Reports (ICSRs) from the Territories. ****

Position Requirements:

• Degree in life science or equivalent with a minimum of 2 years’ experience in Quality in the Pharmaceutical Industry.
• Knowledge of Good Distribution Practice
• Effectively working with cross-functional teams at local/international level.
• Good technical writing and editing skills.
• Fluent in Dutch and English language - both verbal and written. French language preferred.

Benefits:

In return for your talent, we will provide support through smart working, adopting best practice, deploying the latest technology and ongoing personal development. Plus:

• Competitive salary
• Bonus
• Pension scheme
• Private medical insurance

To meet the expectations of our patients and to truly deliver on our Commitment to Life, we are continually looking for people who embrace this spirit. We are committed to providing a culture that offers both inspiration and reward – in terms of compensation and in work satisfaction. And in turn, we want people who’ll bring their unique ideas and diverse approaches, while also aligning to our ultimate goal of making people smile. If this sounds like a company that aligns with your values, we’d love for you to join us in our efforts.

kyowakirin.com/careers

Kyowa Kirin International is an equal opportunities employer.