Senior QA Sterility Assurance Lead
Vor 5 Tagen
This position is responsible for overseeing the day-to-day operations of the QA – Sterility Assurance team. The ideal candidate will have a strong background in microbiology and experience in the pharmaceutical industry.
Responsibilities- Develop and implement the Contamination Control Strategy and Sterility Assurance strategy for the site.
- Ensure compliance with regulatory requirements and industry standards.
- Collaborate with the team to manage quality events and deviations with microbiology impact.
- Write and review SOPs related to sterility assurance.
- Participate in the evaluation of changes that may impact the quality of products.
- Master's degree in Microbiology.
- At least 5 years of experience in microbiology in the pharmaceutical industry.
- Practical knowledge of GMPs and regulatory compliance.
- Extensive background in sterility assurance, process validation, and contamination control.
- Strong interpersonal and communication skills.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
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