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.
