QA Review Support Specialist
vor 2 Wochen
Responsibilities:
- Review cleaning verification and validation protocols, reports, and analytical data for accuracy, completeness, and compliance with SOPs and cGMP requirements
- Ensure acceptance criteria, limits, and test methods meet validation requirements
- Verify calculations, data integrity, and consistency across documentation
- Ensure cleaning validation documentation complies with internal and regulatory standards
- Identify, document, and support the investigation of deviations and nonconformances
- Collaborate closely with Validation, QA, and Manufacturing teams to ensure timely review and approval of documentation
- Contribute to continuous improvement initiatives for cleaning verification and validation processes
Qualifications:
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Microbiology, Engineering, or related field)
- 2+ years of experience in a GMP-regulated environment (pharmaceutical, biotech, or medical device industry preferred)
- Experience with cleaning verification/validation or QA documentation review required
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