Qualified Person & QA Specialist – Radiopharma Release

Quintall; Norway; On-site; NOK 900,000 - 1,200,000; Full time

Job summary

Bayer Norway is seeking a Quality Assurance Specialist / Qualified Person to ensure product release and quality systems across its network of contract manufacturers and partners. The role emphasizes QP certification, batch release, and continuous quality improvements in an international setting.

The successful candidate will work closely with the QA/QP group, support audits, and ensure compliant documentation while collaborating with cross-functional teams in Norway and abroad.

Qualifications

• QP approval in Norway or eligible within a short timeframe.
• Experience in pharmaceutical QA, GMP operations and/or batch release.
• Experience with CMO/supplier oversight, QAAs, deviations, CAPAs and change control.

Responsibilities

• Perform QP certification, disposition and release of commercial and development products, including IMPs.
• Provide QA oversight of CMOs, suppliers and external partners, including batch documentation, deviations, CAPAs, changes and complaints.
• Support efficient release processes for radiopharmaceutical products with complex international supply chains.
• Act as QA representative in product, supply, CMO and development teams.
• Review and approve relevant quality, validation, regulatory and technical documentation.
• Contribute to audits, inspection readiness and continuous improvement of quality systems.

Education

Pharmacist degree

Tools

EU GMP knowledge

Job description

Bayer Norway is seeking a Quality Assurance Specialist / Qualified Person to ensure product release and quality systems across its network of contract manufacturers and partners. The role emphasizes QP certification, batch release, and continuous quality improvements in an international setting.

The successful candidate will work closely with the QA/QP group, support audits, and ensure compliant documentation while collaborating with cross-functional teams in Norway and abroad.