Quality Management System (QMS) SpecialistKYOWA KIRIN LIMITEDHoofddorpNL2021-05-03
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. 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.
Kyowa Kirin International is an equal opportunities employer.
Quality Management System (QMS) Specialist
Kyowa Kirin Pharma B.V. Hoofddorp
• Ensure all aspect of KKH’s GxP Quality Management Systems (QMS) are fully documented and its effectiveness monitored. • Lead, participate in continuous improvement of the established QMS to support MIA/WDA/CDL and MA requirements • Batch certification and release of commercial products in the EU in accordance with EU GMP Annex 16. • Distribution of pharmaceutical products in the EMEA region in accordance with GDP 2013/C343/01. • Facilitate prompt and professional communication of key issues to KKH management as required to ensure effective collaboration towards compliant resolution of issues relating to licence compliance, manufacture, supply and distribution of product. • Provide regular reports of key performance indicators to senior management (local/regional), as part of the QMS, so that the appropriate resources can be allocated and corrective actions implemented, as necessary. • Influence project management meetings in order to assure ongoing activities, identify and address any gaps relating to KKH QMS GxP compliance. • Ensure training programs (induction and refresher) are in place and trainings are performed for all personnel involved in GMP/GDP to ensure compliance with both EU/local cGMDP requirements and Kyowa Kirin QA Policies/Procedures. • Facilitate internal & external audits to assess adherence to EU/local cGMDP requirements and Kyowa Kirin QA Policies/Procedures. • Prepare and maintain Technical (Quality) Agreements with third party organisations involved in the QMS so that roles and responsibilities between the contracted parties are clearly defined and implemented. • Ensure appropriate change control system is in place and lead change controls following quality risk management principles in order to ensure the is change be proportionate and effective. • Ensure appropriate corrective and preventive actions (CAPA) process is in place in order to correct deviations and prevent them in line with the principles of quality risk management. • Closely liaise with local and international internal (e.g. KKS) and external stakeholders.
Job Purpose: Our QA team in the Netherlands is growing and we are now looking for a QMS Specialist to participate in the implementation, execution, delivery and maintenance of the Kyowa Kirin Holdings BV (KKH) GxP Quality Management Systems and become our SME for the KKH QMS.
• Degree in life science or equivalent with demonstrable QMS experience. • Specialist knowledge and experience of pharmaceutical QMS processes and practices. • Firm knowledge of GDP and GMP • Experience of working within the pharmaceutical industry operating in a Quality Assurance position at a manufacturing/distribution site. • Good working knowledge of GxPs and international QMS GxPs, especially in the interpretation of EU and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials • Effectively working with cross-functional teams at local/international level. • Dutch and English language - both verbal and written.
In return for your talent, we will provide support through smart working, adopting best practice, deploying the latest technology and ongoing personal development. Plus: