QA Specialist & Qualified Person — Radiopharmaceuticals

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

Job summary

Bayer Norway is seeking a Quality Assurance Specialist / Qualified Person to lead QP certification, product release, and QA oversight across CMOs and partners. The role focuses on radiopharmaceuticals with international supply chains and requires strong GMP expertise.

Candidates with QP qualifications or those eligible for QP in Norway will be considered. Collaboration across departments and cultures is emphasized in this global company.

Qualifications

• QP approval in Norway or qualifications enabling QP approval within a short timeframe.
• Experience in pharmaceutical QA, GMP operations and/or batch release.
• Understanding of EU GMP, Annex 16, sterile products or radiopharmaceuticals.
• Experience with CMO/supplier oversight, deviations, CAPAs and change control.
• Strong communication 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

English & Norwegian

Education

Pharmacist degree (Norway)

Job description

Bayer Norway is seeking a Quality Assurance Specialist / Qualified Person to lead QP certification, product release, and QA oversight across CMOs and partners. The role focuses on radiopharmaceuticals with international supply chains and requires strong GMP expertise.

Candidates with QP qualifications or those eligible for QP in Norway will be considered. Collaboration across departments and cultures is emphasized in this global company.