QA/RA specialist

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Join us on our journey to save and sustain lives in an experienced Country QA/RA UK, Ireland and Nordic team. Baxter is looking for someone with a few years of experience working in a Quality Assurance / Good Distribution Practice (GDP) environment as RP or similar. 

In this meaningful role you will be named Quality Responsible Person on DKMA §39. (WDA/GDP), you will work closely with other Nordic QA/Responsible Persons to ensure ongoing QA/GDP compliance within Denmark.

As a QA/RA specialist, you will be working with both pharma and medical devices and have an opportunity to participate in different projects to improve our working models in the multi country regulatory environment. You are responsible on Country Quality Assurance activities supported by Global functions.

Essential Duties and Responsibilities:

RP/QA Related:

• Ensure that a quality management system is implemented and maintained within the country.

• You will ensure full compliance of national QA and GDP requirements and processes in the country of responsibility and handle any required activities (Denmark: Laegemedelsloven-lov om laegemiddler 39.

• Supporting the Nordic Region audit program for local Quality Management System and Distributor compliance

• Focus on the management of authorized activities and the accuracy and quality of records.

• Ensure the company follows the EU and National requirements for import and further distribution of pharmaceutical products including preparedness for any corrective actions like recall.

• Decide on the final disposition of returned, rejected, recalled, or falsified products.

• Ensure that complaints, counterfeits and product defects are handled as required and sets quarantine when needed.

• Approve the critical outsourced Functions and customers and ensure they fulfill the Quality Requirements.

• Approve any subcontracted activities which may impact on GDP.

• Ensure distributors of company’s products have an accurate quality system in place and follow additional instructions provided by the company.

• Train the personnel in the relevant processes and requirements.

• Make sure the company follows and is updated of any relevant changes in the pharmaceutical wholesale industry.

• Act as the primary contact for authorities with regards to pharmaceutical wholesales of the company.

RA Related:

• Working closely with other Nordic/UKI and Global RA leads for handling and implementing regulatory strategies for assigned product portfolio and Life Cycle Management Submissions for medicinal products.

• Participate in regulatory activities in support of timely submissions to ensure there are no interruptions in supply.

• Ensure regulatory compliance on applied, approved and/or marketed medicinal products and medical devices in Nordic countries.

• Maintaining internal and external product information databases and change controls.

• Handle product information updates, review translations and labelling updates for both pharma and medical devices.

Qualifications:

• Good knowledge of the regulatory environment of pharmaceutical wholesale.

• Deep understanding of quality systems and quality assurance.

• Experience with medical devices and pharmaceuticals.

• Ability to work efficiently and independently.

• Ability to prioritize work and prioritise multiple tasks simultaneously.

• Good interpersonal and cooperation skills.

• Negotiation skills.

• Ability to lead complex processes.

• Understanding the importance of patient safety.

• Fluent in Danish and English.

Education and/or Experience:

• University degree, preferably in pharmacy or natural sciences.

• 2-5 years of experience within the pharmaceutical industry or distribution

• Experience in MS Office applications

• Preferred/Advantage: Experience with working as a RP in Denmark and with RA departments, working in UKI QA/RA environments, Medical Device and EU Medical Device Regulation.

What we can offer

• Being part of a digital journey and exiting product innovations.

• Independent position with an opportunity to build your own strategy and make a real impact for customers and patients.

• Nice team and work atmosphere.

• A company focusing on Inclusion and Diversity.

If you like the sound of the above role and if this role resonates with you, then we’d love to talk to you!

Reasonable Accommodations

Baxter 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.

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