RP/QA Specialist

Fresenius Kabi AB Filial in Finland

Finland - Helsinki

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On behalf of our client Fresenius Kabi we are now looking for an experienced Responsible Person (VAJ) /Quality Assurance specialist to the Helsinki office:
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, clinical nutrition and biosimilars. Our products and services are used to help critically and chronically ill patients. Fresenius Kabi sales exceed €8 billion, the company employs more than 43,000 people worldwide.

Fresenius Kabi Ab, Finland branch supplies essential medicines, clinical nutrition and blood transfusion products to the biggest hospitals and blood banks in Finland. Our employees share one passion: committed to life, which drives us to make a difference in the quality of life of patients.

The role:
Responsible Person, Quality Assurance Manager, National Safety Officer is responsible for the Quality Assurance and Quality Management related activities at the Fresenius Kabi market unit Finland. The RP/QA Manager's main task is to ensure that all activities in the aforementioned areas are performed according to applicable requirements.

A Responsible Person for GDP position holder is responsible for the wholesale license. As National Safety Officer (NSO), acts as responsible person for Pharmacovigilance, vigilance for EN products and devices at the Fresenius Kabi in Finland and overviews Medical Information at the Fresenius Kabi in Finland.

Main accountabilities:
Accountabilities in Quality Management and Quality Management System:

• Maintenance and improvement of the Quality Management system for Market Unit Finland in compliance with the corporate and local requirements and in compliance with ISO 9001.
• QMR (Quality Management Representative) for MU Finland Fresenius Kabi AB
• Handling QMS documentation, including the implementation of gSOPs, coordination and approval of locals SOPs and other
• Management and follow-up of CAPAs, deviations and change control
• Planning and conducting of internal and external audits and internal inspections
• Planning and performing internal training on the Quality Management System, ISO 9001 and GDP areas
• Organizing Management Reviews
• Taking care of product complaints and functioning as a complaint officer
• Review and approval of Quality Agreements on behalf of the MU (as RP)
• Performing supplier- and distributor audits on behalf of the MU
• Maintenance of the wholesale license and acting as primary contact point for authorities and both external and internal stakeholders regarding wholesale license and quality
• Preparation and submission of annual notifications of medicinal product samples to Fimea.
• Acting as the national contact person for narcotics, including supervision of appropriate bookkeeping of imported, exported, distributed and destroyed narcotic drugs and the submission of estimates and actual data to Fimea

Accountabilities as National Safety Officer:

• Responsibility of the National Safety Officer MU FI as defined in the relevant corporate and local SOPs, including collecting safety data, reporting to Global Vigilance and local authorities as outlined in national legislation, ensuring sufficient training in vigilance topics of FI employees and documentation of vigilance-related activities as outlined in the relevant corporate and local SOPs

24/7 availability due to RP and NSO tasks

• Acting as the primary contact point for authorities and both external and internal stakeholders regarding pharmacovigilance and GDP
• Responsibility of the medical information system

Experience and Qualifications:

• MSc Pharm, licensed
• Experience in Quality Assurance and GDP in the healthcare industry
• Knowledge and experience in Vigilance
• Fluent in Finnish and English (oral and written)

We are looking forward to receiving your application by 29th Sep 2024. PharmaRelations is assisting in the recruitment. Please send your CV and application via PharmaRelations website. We are not able to handle CVs via email. We handle the applications and interviews already before the due date and may proceed with suitable candidates, hence it may be beneficial to apply early. If you have any questions, please feel free to contact contact Piia Rantala, 040 756 7664 or Sari Reti, 040 643 2545 at PharmaRelations.