QA Manager/RP DC Lund

1 week ago

Lund, Skåne, Sweden Baxter Full time

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 based in Lund, Sweden with a few years of experience working in Quality Assurance and as RP or doing similar tasks.

As the QA Manager/Responsible Person your main job is to make sure that everything related to the quality of drugs sold wholesale follows the rules and ISO standards. You will also assist in making sure all the processes and procedures for quality and following the law are set up accurately. This includes helping to follow rules like EU GDP and HSLF-FS 2021:95. You will also work on setting up systems for quality in how drugs are distributed and serviced.

Essential Duties and Responsibilities:

Secure that Good Distribution Practice is carried out throughout distribution of medicinal products. Secure that returns of non-defective medicinal products are handled correctly, according to its storage condition. Assess if returned non-defective medicinal products can be taken to saleable stock. Ensure that the quality system is implemented and maintained. Ensure proper management of authorized activities and accuracy and quality of records. Ensure initial and continuous training programs are performed at the distribution center where drugs products are stored, and from which are distributed. Ensure that customer complaints are effectively processed. Ensure that suppliers and customers are approved in accordance with the procedures. Ensure that self-inspections are performed according to the established plan and necessary corrective actions are put in place. Ensure that delegated duties are properly documented. Ensure that any additional requirements imposed on certain products by national law are adhered.

Qualifications:

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 multiple tasks. Good interpersonal and collaboration skills. Negotiation skills. Ability to lead complex processes. Understanding the importance of patient safety.

Education and/or Experience:

Degree or equivalent experience in either pharmacy, medicine, chemistry, pharmaceutical chemistry and technology, biology. Be approved as Responsible Person by MPA. Proven 5 years' experience in qualitative analysis of medicinal products, quantitative analysis on active substances, tests and verifications aimed to certify the quality of the products. Experience with Good Manufacturing Practice and Good Distribution Practice Experience in MS Office applications. Excellence verbal and written skills both Swedish and English. Finnish or Norwegian is an advantage.

What we can offer

Being part of a digital journey and exiting product innovations. 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

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