QA Specialist
Workplace: Malmö, Sweden
Expires: July 31, 2025
A role focused on ensuring pharmaceutical and medical devices quality through independent work under quality systems such as ISO9001 and ISO13485. The position involves document review, release of materials, deviation handling, and cooperating across departments to support risk management and continuous quality improvement.
Main requirements:
  • Relevant education (MSc or PhD) within biomedicine, molecular biology, microbiology, chemistry, pharmacology
  • 2-3 years of experience in quality work and knowledge of regulatory requirements in the pharmaceutical industry
  • Good knowledge and experience with ISO9001 and ISO13485 and other relevant regulatory frameworks
  • Experience in pharmaceutical or technical product development and risk management
  • Experience in release of pharmaceuticals and production materials
  • Fluency in Swedish, both spoken and written
Responsibilities:
  • Establish, maintain and improve quality systems linked to ISO9001 and ISO13485
  • Issue and update quality documentation during product development
  • Quality review and approval of documents related to ISO9001, ISO13485 and product development documentation
  • Preparation for release of purchased materials for production
  • Compile quality documentation
  • Support risk management in pharmaceutical and medical device development
  • Collaborate with other departments like QC, packaging development, formulation and analytical development
  • Participate in staff training within the department
  • Support during internal and external regulatory inspections
  • Contribute to continuous quality improvement
Required hard skills:
  • Experience working under quality systems ISO9001 and ISO13485
  • Regulatory knowledge in pharmaceutical and medical devices sectors
  • Experience with pharmaceutical quality release and production material approval
  • Knowledge of GMP (preferred)
Recommended hard skills:
  • Experience conducting or assisting in inspections
  • Experience in risk management and technical product development
Soft skills:
  • Problem-solving mindset
  • Decision-making ability
  • Engagement and determination
  • Curiosity and integrity
  • Accuracy, flexibility and structured approach
  • Solution-oriented attitude
  • Ability to help others and improve work methods
Frameworks:
  • ISO9001
  • ISO13485
Natural languages:
  • Swedish (Proficient)
Cultural skills:
  • Supportive and inclusive culture
  • Diversity valued
  • Career development focused
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