Quality Control Specialist for Medicinal Products

13 hours ago


Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time

About Us

Sobi is a global biopharmaceutical company with a strong commitment to improving the lives of people with rare and debilitating diseases. Our company has a presence in over 30 countries, employing over 1,800 talented individuals who share our vision of creating innovative solutions to address the needs of patients with rare diseases.

We value diversity and inclusion in our workplace and encourage applications from individuals who share our passion for making a difference. If you are a driven and motivated professional looking to contribute to a dynamic team, we would love to hear from you.

About the Role

This role involves serving as a quality control specialist for medicinal products, overseeing product release, supplier qualifications, and quality technical agreements. The successful candidate will ensure compliance with GMP & GDP regulations and Sobi's quality system.

Your Key Responsibilities

  • Ensure compliance with GMP & GDP regulations and Sobi's Quality System.
  • Oversee product release, supplier qualifications, and quality technical agreements.
  • Implement and maintain quality risk assessments and KPIs.
  • Manage quality issues, audits, and change requests.
  • Lead quality initiatives and act as a quality representative in projects.

Requirements

  • Degree in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science, including courses in inorganic, organic, analytical, physical, and medical chemistry, biochemistry, physiology, galenic pharmacology/pharmaceutical technology, pharmacology, and toxicology.
  • More than 10 years of experience within pharmaceutical, biotech products. More than 5 years of experience in QA operation or external quality including supplier quality management (GMP, GDP).
  • In-depth understanding of GMP requirements of FDA; EMEA, or other Health Authorities.
  • Strong understanding of risk assessment and risk management fundamentals/tools.
  • Excellent verbal and written communication skills.
  • Fluently spoken and written English.


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