Radiopharmaceutical QA/QP Specialist — Norway

Bayer Norge; Oslo; On-site; NOK 900,000 - 1,100,000; Full time

Job summary

Bayer Norge is seeking a Quality Assurance Specialist / Qualified Person to lead QP certification, product release, and QA oversight for radiopharmaceuticals. The role involves collaboration with CMOs and suppliers, and driving continuous improvement of quality systems in an international setting.

Applicants should have QP eligibility or Norway-based QP approval, strong pharma QA/GMP experience, and fluency in English and Norwegian.

Qualifications

• QP approval in Norway, or qualifications enabling QP approval within a short timeframe.
• Strong experience from pharmaceutical QA, GMP operations and/or batch release.
• Good understanding of EU GMP, preferably including Annex 16, sterile products or radiopharmaceuticals.
• Experience with CMO/supplier oversight, QAAs, deviations, CAPAs and change control.
• Structured, independent and able to make sound quality decisions under time pressure.
• Strong communication skills in English and Norwegian.

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.

Skills

QP approval

GMP operations

QA oversight

CMO oversight

radiopharmaceuticals

Quality systems

Education

Pharmacist degree

QP eligibility

Tools

Quality Management System

Job description

Bayer Norge is seeking a Quality Assurance Specialist / Qualified Person to lead QP certification, product release, and QA oversight for radiopharmaceuticals. The role involves collaboration with CMOs and suppliers, and driving continuous improvement of quality systems in an international setting.

Applicants should have QP eligibility or Norway-based QP approval, strong pharma QA/GMP experience, and fluency in English and Norwegian.