Mission Description:
- Oversee Quality compliance in validation processes, with an emphasis on Data Integrity.
- Collaborate with Subject Matter Experts to conduct gap analyses and risk evaluations prior to qualification efforts.
- Participate in investigations of validation discrepancies, aiding in the review and approval of discrepancy reports and ensuring CAPA closures.
- Review and authorize various validation documentation, such as protocols and reports.
- Provide assistance and solutions for validation-related inquiries and challenges.
- Evaluate and approve routine SOPs, forms, and other relevant documents, including Manufacturing Batch Records.
Profile Requirement:
- Background in Quality Assurance or Quality Control within a regulated setting.
- Familiarity with validation processes and principles of Data Integrity.
- Strong analytical and problem-solving capabilities.
- Excellent communication and collaborative skills.
- Can start by November.