QA Specialist: CQV & Cleaning Validation Leader

Bavarian Nordic

Schweiz

Remote

CHF 90,000 - 130,000

Full time

2 days ago
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Job summary

Bavarian Nordic in Switzerland seeks a QA Specialist Qualification & Validation to ensure compliant CQV and Cleaning Validation activities across the site. You'll review strategies, plans, and reports for facilities, utilities, equipment, and systems while coordinating with Engineering, Manufacturing, and MSAT to ensure timely execution.

Required is a university degree in a relevant field and strong knowledge of EU GMP Annex 15.

Qualifications

  • Experience in Quality Assurance, Qualification and/or Validation in pharma.
  • Strong knowledge of CQV, Cleaning Validation and EU GMP Annex 15.
  • Ability to identify compliance risks and drive improvements.

Responsibilities

  • Provide QA oversight and approval for CQV and Cleaning Validation activities.
  • Develop, review and approve CQV strategies, plans, protocols and reports.
  • Collaborate with Engineering, Manufacturing, MSAT and other quality functions to ensure compliant execution.
  • Support audits and inspections, ensuring readiness and robust documentation.
  • Act as SME for EU GMP requirements and guide stakeholders.

Skills

CQV knowledge
GMP awareness
Regulatory compliance

Education

University degree in Pharmacy, Life Sciences, Engineering, Chemistry or equivalent

Job description

Bavarian Nordic in Switzerland seeks a QA Specialist Qualification & Validation to ensure compliant CQV and Cleaning Validation activities across the site. You'll review strategies, plans, and reports for facilities, utilities, equipment, and systems while coordinating with Engineering, Manufacturing, and MSAT to ensure timely execution.

Required is a university degree in a relevant field and strong knowledge of EU GMP Annex 15.

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