CQV & Cleaning Validation QA Specialist

Bavarian Nordic; Bern; On-site; CHF 90,000 - 130,000; Full time

Job summary

Bavarian Nordic is seeking a QA Specialist for Qualification & Validation to ensure compliant Commissioning-Qualification-Validation and Cleaning Validation activities across our site in Switzerland. You will collaborate with Engineering, Manufacturing, MSAT and quality functions to maintain high quality standards and regulatory compliance.

You will provide QA oversight, develop CQV strategies and support audits and inspections, acting as SME for EU GMP requirements (EU GMP Annex 15).

Qualifications

• University degree in Pharmacy, life sciences, engineering or chemistry.
• Experience in Quality Assurance, Qualification and/or Validation in pharma or regulated industry.
• Strong CQV and Cleaning Validation knowledge and EU GMP Annex 15 familiarity.

Responsibilities

• Provide QA oversight and approval for CQV and Cleaning Validation activities.
• Develop and approve CQV strategies, plans, protocols and reports.
• Collaborate with Engineering, Manufacturing, MSAT and quality functions.
• Support audits and inspections and ensure readiness.
• Act as SME for EU GMP requirements and provide guidance.
• Drive continuous improvement and deviation handling in CSV.

Skills

CQV knowledge

Cleaning Validation

Regulatory compliance

Cross-functional collaboration

Attention to detail

Education

University degree in Pharmacy/Life Sciences/Engineering/Chemistry

Job description

Bavarian Nordic is seeking a QA Specialist for Qualification & Validation to ensure compliant Commissioning-Qualification-Validation and Cleaning Validation activities across our site in Switzerland. You will collaborate with Engineering, Manufacturing, MSAT and quality functions to maintain high quality standards and regulatory compliance.

You will provide QA oversight, develop CQV strategies and support audits and inspections, acting as SME for EU GMP requirements (EU GMP Annex 15).