Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Senior QA Sterility Assurance
Thermo Fisher Scientific Inc., Lengnau is seeking a highly motivated and experienced individual to join our team as a Senior QA Sterility Assurance. This is an exceptional opportunity to be part of a world-class organization that is dedicated to making the world healthier, cleaner, and safer.
As the Senior QA Sterility Assurance, you will play a crucial role in ensuring the flawless sterility of our products. You will be responsible for strictly adhering to quality assurance processes and procedures to ensure the sterility of our products. Your proven expertise in QA processes and attention to detail will be essential in successfully implementing and maintaining a robust sterility assurance program.
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Responsibilities:
- Have quality oversight of all sterility assurance and microbial related-topics in Lengnau site.
- Responsible for setting up the overall microbial control concepts on the Lengnau site.
- Ensure the review and approval as a quality function for protocols, reports, procedures, and other relevant documents required for contamination control strategy, contamination investigation, sterility hold time validation activities.
- Contribute to the implementation of Lifecycle Validation concepts at Lengnau and act as the Subject Matter Expert for the area of responsibility during health authority inspections and customer audits.
- Perform environmental monitoring to ensure sterility in manufacturing areas.
- Investigate and resolve sterility-related issues.
Requirements:
- Master Degree in Microbiology or equivalent experience in the field.
- Proven experience (minimum 3 years) in microbiology in the pharmaceutical industry.
- Strong knowledge of sterility assurance principles and regulations.
- Exceptional attention to detail and analytical skills.
- Excellent communication and collaboration abilities.
- Language: Fluent English required, with some proficiency in German beneficial (written and spoken).
Join Thermo Fisher Scientific Inc., Lengnau and be part of a highly ambitious team that is committed to delivering world-class products. Apply today and start your journey towards making a difference in the lives of others.