Validation Quality Assurance Specialist
4 weeks ago
Key Responsibilities:
- Act as an integral member of the Quality Systems team, ensuring effective quality oversight for validation activities with an emphasis on Data Integrity.
- Collaborate with Subject Matter Experts to support the validation team in conducting gap analyses and risk assessments prior to qualification activities, recommending mitigation plans for any identified gaps.
- Participate in investigations of validation discrepancies and assist in reviewing and approving discrepancy reports to support the closure of Corrective and Preventive Actions (CAPA).
- Review and authorize validation documents, including protocols, reports, and related materials.
- Provide guidance on validation-related inquiries and challenges throughout the process.
- Review and approve routine Standard Operating Procedures (SOPs), forms, and other pertinent procedures, including Manufacturing Batch Records.
Qualifications:
- Extensive experience in quality oversight of validation activities, particularly concerning Data Integrity requirements.
- Proficient in conducting gap analyses and risk assessments while proposing effective mitigation strategies.
- Experienced in handling discrepancy investigations and managing CAPA processes.
- Expertise in reviewing and approving validation documents and operational procedures.
- Strong communication and problem-solving abilities, with a focus on compliance and continuous quality improvement.
Tell employers what skills you have
CAPA
Agile Testing
Microsoft Excel
Verbal Communication
Quality Assurance
Quality Improvement
Release Management
Medicine
Test Cases
Healing
Compliance
General Insurance
Audits
Integration Testing
Manufacturing
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