Validation and Compliance Expert
1 week ago
Job Summary
As a QA Validation Specialist at Thermo Fisher Scientific, you will play a critical role in ensuring the quality and integrity of our products and processes. This position requires a strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements.
Key Responsibilities
- Provide validation support to various departments, including equipment, systems, and facilities, to ensure compliance with regulatory requirements.
- Lead and coordinate validation and qualification activities, including equipment, facilities, systems, cleaning, distribution, and computerized systems validation (CSV).
- Develop and maintain validation protocols, reports, and documentation to ensure site compliance and adherence to regulatory requirements.
- Collaborate with cross-functional teams to identify and implement process improvements and optimize validation activities.
- Conduct root cause analysis and deviation resolution for validation exceptions.
- Represent QA validation in multi-functional meetings and projects as required.
Requirements
- Relevant pharmaceutical or GMP experience.
- Previous experience in validation or CSV roles.
- Knowledge of GMP legislation and regulatory requirements.
- Excellent communication and presentational skills.
- Ability to establish effective working relationships and communicate effectively with stakeholders.
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