The company seeks a Senior QA Specialist for Cleaning Validation in Visp, Switzerland. The role focuses on supporting validation specialists throughout the cleaning validation lifecycle, ensuring compliance with procedures and regulatory guidance.
This position is based in Visp, Switzerland, and centers on assisting validation specialists across the entire lifespan of cleaning validation activities. The specialist ensures that all processes align with internal protocols and external regulatory standards.
Responsibilities
- Assist validation specialists throughout the entire cleaning validation process to maintain adherence to company procedures and regulatory standards.
- Review and approve validation documentation, including soil characterization studies, risk assessments, validation protocols, and reports.
- Support Cleaning Development teams during the development phase by reviewing and approving cleaning strategy papers and swab position assessments.
- Review and approve annual cleaning review reports.
- Ensure consistent implementation and continuous improvement of validation procedures at the Visp site.
- Participate in internal and external audits and inspections.
Requirements
- Academic degree in Chemistry, Biotechnology, or a related field.
- Extensive experience in biopharmaceutical manufacturing, preferably within a validation function, with a strong background in cGMP.
- Broad knowledge of manufacturing processes in a GMP environment.
- Experience interacting with various internal departments and regulatory agencies (e.g., Swissmedic, FDA).
- Fluency in English is required.
Nice to have
- Good German language skills.
What the company offers
- An agile career path and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- A variety of benefits depending on role and location.
- Relocation assistance is available for eligible candidates and their families, if needed.
About the company
Lonza places its people at the center of its success. The company fosters a collaborative, accountable, excellent, passionate, and integrity-driven environment. It values diversity and is committed to creating an inclusive workplace for all employees.
- People are considered the greatest strength.
- Core values include Collaboration, Accountability, Excellence, Passion, and Integrity.
- Diversity is valued, and an inclusive environment is maintained for all employees.
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