QA OfficerKYOWA 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.
Kyowa Kirin Pharma B.V. Hoofddorp
• Upon product receipt at EU Central Supply Hub, obtain for each batch the relevant documentation • Verify obtained information for correctness and assess against defined requirements. • Provide batch disposition proposal to RP based upon information assessment. • Prepare and share authorization to ship upon RP batch disposition decision. • Record product inbound and outbound in related systems. • Perform physical & report yearly product stock reconciliation in cooperation with internal/external stakeholders. • Prepare disposition decision proposal in case of returns & give written destruction approval when applicable. • Liaise with GDP contractors in order to ensure product storage and transport requirement are adhered. • Participate in the operational activities related to management of GDP related non-conformities, deviations and temperature excursions, including management of CAPAs. • Participate in audits at GDP contractors as applicable.
To support in managing KKH’s narcotic import and export activities related to the active CDL:
• Supervise import license and export license application activities. • Report any loss, theft or unresolved discrepancies immediately internally and prepare communication to be shared with internal and external stakeholders. • Prepare & submit monthly and annual CDL reporting to CIBG. • CLD related record keeping.
To support in Customer Control Management:
• To inform the RP of receipt of an order from a new customer. • To process orders from customers only when the customer has been approved by the RP. • To collect all relevant information to assess the appropriate licensing status of suppliers of medicinal products. • Monitor distribution contractors quality performance according a set of defined metrics with periodic reporting. • 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). • Work closely with the service providers in the territory.
Job Purpose: We are looking for an experienced QA Officer to join our team in the Netherlands, to provide support ensuring GDP compliance of Kyowa Kirin Holdings B.V. (KKH) for the certification, distribution, supply and marketing of pharmaceutical products in the EMEA region, including narcotics.
• Degree in life science or equivalent with proven experience in Quality Assurance in the Pharmaceutical Industry. • Knowledge of Good Manufacturing and Good Distribution Practices and processes related to handling (import/export) of narcotics is desirable • 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: