QA CQV & Cleaning Validation Specialist

Bavarian Nordic Berna GmbH; Köniz; On-site; CHF 90,000 - 130,000; Full time

Job summary

Bavarian Nordic Berna GmbH is seeking a QA Specialist in Qualification & Validation to oversee CQV and Cleaning Validation activities at our Bern site. You will review strategies, plans and reports, ensuring compliance with EU GMP and company standards while coordinating with Engineering, Manufacturing and MSAT teams.

The role emphasizes rigorous documentation, audit support, and proactive quality improvements to sustain robust qualification and validation processes across facilities and systems.

Qualifications

• Strong knowledge of CQV and Cleaning Validation and EU GMP requirements.
• Ability to review and approve CQV/CSV documentation and reports.
• Experience supporting audits and inspections in a regulated setting.

Responsibilities

• Provide QA oversight, review and approval for CQV and Cleaning Validation activities across the site.
• Develop, review and approve CQV and Cleaning Validation strategies, plans, and reports for facilities, utilities, equipment and computerized systems.
• Collaborate with Engineering, Manufacturing, MSAT and other quality functions to ensure compliant execution.
• Support audits and inspections related to CQV and Cleaning Validation and ensure robust documentation.
• Act as SME for EU GMP requirements and drive continuous improvement across teams.

Skills

GMP knowledge

CQV & Cleaning Validation

Regulatory compliance

Cross-functional collaboration

Attention to detail

Education

University degree in Pharmacy, Life Sciences, Engineering, Chemistry or comparable field

Job description

Bavarian Nordic Berna GmbH is seeking a QA Specialist in Qualification & Validation to oversee CQV and Cleaning Validation activities at our Bern site. You will review strategies, plans and reports, ensuring compliance with EU GMP and company standards while coordinating with Engineering, Manufacturing and MSAT teams.

The role emphasizes rigorous documentation, audit support, and proactive quality improvements to sustain robust qualification and validation processes across facilities and systems.