Quality Assurance Specialist

4 days ago

Sundbyberg Municipality, Sweden BAXTER Full time
About the Role

Baxter is a leading healthcare company that is deeply connected by its mission to save and sustain lives. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services, and contributing to the company's success.

Key Responsibilities
  • Manage and continuously improve our quality system to ensure compliance with regulatory requirements.
  • Support the Responsible Person and/or Qualified Person in areas related to QA and compliance to and with National Regulations.
  • Initiate, participate, and lead quality-related projects within the Marketing Company.
  • Ensure control of approval, distribution, and filing of quality documents.
  • Support the implementation of the Quality Manual, including monitoring of the performance of the quality system.
  • Implement and manage Nordic Field corrective actions for both medical devices and pharmaceuticals.
  • Coordinate Complaint management process in the Nordics.
  • Handle non-conformity reports for Marketing Company. CAPA-initiator.
  • Ensure that systems and instructions are in place and maintained to train employees in quality system compliance.
  • Support business leaders in the assigned countries in quality-related matters and inquiries.
  • Support Baxter customers' quality-related inquiries.
  • Support the Nordic Region audit program for local Quality Management System and Distributor compliance.
  • Support in Audits and Inspections (internal/external) as needed.
  • Support the implementation of the Corporate Quality Manual and the applicable ISO 9001 & ISO 13485 standards and GDP requirements at the Nordic level.
  • Support in application of the processes and development of procedures related to above-mentioned activities.
  • Have continuous contacts both with country Regulatory Affairs Specialists as well as Country Regulatory Affairs authorities.
  • Act professionally and efficiently to serve customers (internal and external) with high-quality information in a timely manner.
Possible/Potential RA Tasks
  • Working closely with other Nordic and Global RA leads to managing and implementing regulatory strategies for assigned product portfolio and Life Cycle Management Submissions for medicinal products.
  • Maintain internal and external product information databases and change controls.
  • Handle product information updates, review translations, and labelling updates for both pharma and medical devices.
Requirements
  • Based in Sweden and familiar with GDP requirements and the regulatory environment in all Nordic countries for pharma products and/or medical devices.
  • Self-motivation and ability to work in a cross-national and cross-functional matrix organization.
  • Skills and personal attributes for international teamwork, dedication to meet both internal and external customer expectations.
  • Ability to liaise with different functions involved, Regulatory Affairs, Pharmacovigilance, Customer Service, Supply Chain, Nordic Warehouse, Technical Service, and Business.
  • Good interpersonal and communication skills.
  • High work ethics and deep understanding of the quality requirements with medicinal products.
  • Communicate fluently in Swedish and in English internally and externally.
Education and/or Experience
  • Bachelor's/master's degree or equivalent experience, preferably in Pharmacy, Life sciences, or corresponding Chemical engineering.
  • Minimum 3 years professional experience of Quality Assurance work in pharmaceutical companies and in quality systems.
  • Familiar with the regulatory environment in all Nordic countries.
  • Good knowledge in ISO 9001, ISO 13485 standards, EU GDP, and Local GDP requirements at Nordic level.
  • Experience in National Competent Authorities (NCA) communication in Sweden and other Nordic countries.
  • Preferred/Advantage: Experience of working in Regulatory affairs, working in a UK/Ireland/Malta/Nordic QA/RA environment, Medical Device, and EU Medical Device Regulation.
What We Can Offer
  • A challenging opportunity for you and a chance to work in a diverse and experienced team with a great mix of people.
  • Independent position with an opportunity to build your own strategy and make a real impact for customers and patients.
  • A chance to further build your professional experience in healthcare.
  • Internal training tailored to business needs and career goals.
  • Stability of employment in a recognizable and established company.

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