CQV & Cleaning Validation QA Specialist (EU GMP Expert)

Bavarian Nordic; Köniz; Presencial; CHF 90.000 - 130.000; Jornada completa

Descripción de la vacante

Bavarian Nordic seeks a QA Specialist in Qualification & Validation to ensure compliant Commissioning-Qualification-Validation and Cleaning Validation activities across our site. You will review strategies, plans and reports and collaborate with Engineering, Manufacturing, MSAT and quality teams to drive quality and continuous improvement.

You will act as SME for EU GMP requirements, including EudraLex Volume 4, Annex 15, and support audits and inspections with robust documentation.

Formación

• Bachelor-level or higher degree in a scientific/technical field (pharmacy, life sciences, engineering or chemistry).
• Solid understanding of CQV and Cleaning Validation in regulated environments.
• Experience with EU GMP requirements, especially EudraLex Volume 4, Annex 15.

Responsabilidades

• Provide QA oversight and approval for CQV and Cleaning Validation activities.
• Develop and review CQV/Cleaning Validation strategies, plans, protocols and reports.
• Collaborate with Engineering, Manufacturing, MSAT and quality to ensure compliant execution of qualification/validation tasks.
• Support audits and inspections and ensure robust documentation.

Conocimientos

GMP compliance

Cross-functional collaboration

Educación

University degree (Pharmacy/Life Sciences/Engineering/Chemistry)

Descripción del empleo

Bavarian Nordic seeks a QA Specialist in Qualification & Validation to ensure compliant Commissioning-Qualification-Validation and Cleaning Validation activities across our site. You will review strategies, plans and reports and collaborate with Engineering, Manufacturing, MSAT and quality teams to drive quality and continuous improvement.

You will act as SME for EU GMP requirements, including EudraLex Volume 4, Annex 15, and support audits and inspections with robust documentation.