QA Specialist Qualification & Validation (f/m/d)

Bavarian Nordic; Schweiz; Remote; CHF 90,000 - 130,000; Full time

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

## QA Specialist Qualification & Validation (f/m/d)Apply: Thorishaus: Full time: Posted Today: JR101592As a QA Specialist Qualification & Validation, you will play an important role in ensuring compliant and robust Commissioning-Qualification-Validation and Cleaning Validation activities across our site. Working closely with cross-functional teams, you will help maintain high quality standards and ensure regulatory requirements are consistently met.**Your tasks*** Provide QA oversight, review and approval for CQV and Cleaning Validation activities across the site, ensuring compliance with regulatory and company requirements* Develop, review and approve CQV and Cleaning Validation strategies, plans, protocols and reports for new and existing facilities, utilities, equipment and computerized systems* Collaborate closely with Engineering, Manufacturing, MSAT and other quality functions to ensure compliant and timely execution of qualification and validation activities* Support audits and inspections related to CQV and Cleaning Validation, ensuring inspection readiness and robust documentation* Act as Subject Matter Expert (SME) for EU GMP requirements, including EudraLex Volume 4, Annex 15, and provide guidance to relevant stakeholders* Drive quality, compliance and continuous improvement, including supporting changes and corrective actions related to CSV and Cleaning Validation and sharing expertise across teams**About you*** University degree in Pharmacy, Life Sciences, Engineering, Chemistry or a comparable scientific/technical field* Relevant professional experience in Quality Assurance, Qualification and/or Validation within the pharmaceutical or a similarly regulated industry* Strong knowledge of CQV and Cleaning Validation, as well as applicable GMP requirements, particularly EU GMP / EudraLex Volume 4, Annex 15* Strong quality mindset and attention to detail, with the ability to identify compliance risks and drive continuous improvement* Excellent collaboration and communication skills, with experience working effectively across functions such as Engineering, Manufacturing, MSAT and other quality services* A proactive and adaptable mindset, combined with strong organizational skills and the ability to manage change and drive topics independentlyWe provide an opportunity to be part of an international company that boasts exceptional technology and a determined team. Join our team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and professional skills.**Are you ready to join us in our mission?**If this sounds like the next step in your career, we would love to hear from you. Simply click the \"APPLY\" button on the right side of the page and you will be redirected to our application form.We are conducting interviews on an ongoing basis and encourage you to apply as soon as possible. Applications submitted via email will not be considered.