CQA Specialist - 12 month fixed contract

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your job at Vantive

As the CQA Specialist for the UK, you will primarily oversee ensuring compliance with Good Distribution Practice (cGDP) and Good Manufacturing Practice (GMP) of Medicinal Products for Human Use and in accordance with the Council Directive 93/42/EEC concerning Medical Devices, as well as the Vantive Quality Management System.

Reporting to the CQA Manager for UKI, this is a 12 month fixed-term contract and will be home-based within the UK.

What you’ll be doing :

• Support the implementation and maintenance of the Quality Management System, completing Gap Analysis and risk assessments and ensuring that local systems comply with Vantive Corporate and Regulatory requirements.
• Process local documentation on TcU.
• Manage local field action implementation, including coordinating implementation and execution of field actions according to Vantive procedures; liaising with local stakeholders; completing customer communications and due diligence; managing Ministry of Health communication (MOH) communications; reconciliation activities and closure.
• Support complaint handling: responsible for initiation / completion of Medicinal Product Complaint Risk Assessments, notification of reportable Quality Defects to the HPRA and any HPRA correspondence relating to Quality defect.
• Support the correct local QA setting up of products in the enterprise management system (JDE)/3PL warehouses
• System release of UK products/Re-certification of medicinal products received into IE from the UK including reviewing temperatures of shipments and assessing the impact of temperature excursions in the supply chain.
• Support supplier approval and maintenance of third-party products, including Supplier Corrective Action Requests including initiation and review of technical quality agreements.
• Re-verification of customer bona fides (IE only)
• Participate in the internal and external audit program and ensure that any resulting corrective/preventive actions are completed with the agreed timescales.
• Support management of non-conformances including issue investigation and execution of corrective actions; support the Change Control process.
• Carry out additional Quality related tasks and assignments as required by the Department Manager.

What you’ll bring :

• Proven experience in a Quality role working with the Ministry of Health (or other governmental health departments) within the pharmaceutical and/or medical device industry
• Demonstrated experience successfully planning and conducting internal audits, as well as supporting audits for the Ministry of Health or other notified bodies.
• Outstanding knowledge of country specific (MHRA/HPRA) and EU regulations
• Working expertise of Quality Management Systems (e.g. ISO9001, ISO13485)
• Well organised with an eye for detail, you have excellent communication skills and flourish working within an international and dynamic team

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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