Senior QA Scientist (Biopharmaceuticals, Copenhagen)

Job summary

This role focuses on quality assurance within the Quality Control (QC) sector of a biopharmaceutical organization. The Senior QA Scientist will ensure compliance with GMP standards and support various QA activities related to QC documentation and manufacturing processes.

Qualifications

• Master's degree in a relevant natural science field (e.g., Pharmacy, Biotechnology, Biology, Chemistry)
• Minimum of 5 years of experience in QA, particularly within QC or manufacturing environments
• Strong understanding of GMP requirements and experience in QA oversight
• Fluency in written and spoken English is essential for effective communication

Responsibilities

• Collaborate closely with QC and other QA teams to ensure compliance with quality standards
• Guide requirements for commercial production support
• Participate in laboratory investigations, manage deviations, and handle change controls and CAPAs
• Review and approve analytical method validation protocols and reports as needed

Skills

• Strong problem-solving skills and ability to meet deadlines
• Excellent communication and collaboration skills
• Proactive and supportive attitude towards colleagues and customers

Education

• Master's degree in a relevant field of natural science

Tools

• Familiarity with GMP documentation and quality systems