Radiopharma QA/QP Specialist — Release & Compliance

Bayer Nordic; Oslo; On-site; NOK 900,000 - 1,200,000; Full time

Job summary

Bayer Norway is seeking a Quality Assurance Specialist / Qualified Person to join the QA/QP group in Oslo. The role centers on release of products manufactured by contract manufacturers, development quality tasks, and ongoing optimization of our quality systems in a multinational setting.

The successful candidate will have QP approval in Norway or qualifications enabling rapid approval, plus strong GMP knowledge, batch release 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

Batch release

Quality documentation

CMO oversight

Project management

English & Norwegian communication

Job description

Bayer Norway is seeking a Quality Assurance Specialist / Qualified Person to join the QA/QP group in Oslo. The role centers on release of products manufactured by contract manufacturers, development quality tasks, and ongoing optimization of our quality systems in a multinational setting.

The successful candidate will have QP approval in Norway or qualifications enabling rapid approval, plus strong GMP knowledge, batch release experience, and fluency in English and Norwegian.