CSV Consultant with Quality Assurance Validation (QAV)
Location: Framingham, MA
Duration: 6+ Months
Role Summary:
We are seeking a highly skilled CSV Consultant with a focus on Quality Assurance Validation (QAV) to oversee the validation of computerized systems, ensuring compliance with regulatory standards and alignment with quality frameworks. This position requires a proactive approach to managing validation activities and collaboration with cross-functional teams to support manufacturing, laboratory, and quality management systems.
Responsibilities:
Develop, execute, and review validation documentation, including Validation Master Plans, protocols (IQ, OQ, PQ), and reports for computerized systems across manufacturing, laboratory, and quality management processes.
Provide QAV oversight for validation deliverables, ensuring compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and other relevant regulatory standards.
Perform risk assessments to identify potential compliance gaps and implement effective controls during validation activities.
Support the development and periodic updates of SOPs, policies, and procedures related to CSV, aligning with industry standards and data integrity requirements.
Conduct periodic reviews of validated systems to ensure ongoing compliance and efficiency.
Offer recommendations to address compliance issues identified during risk assessments or audits, ensuring timely resolution.
Provide management updates on validation progress, findings, and interim control measures to maintain oversight of system compliance.
Collaborate with stakeholders to ensure adherence to best practices during system implementation and operation.
Qualifications:
Expertise in CSV processes with a focus on Quality Assurance and Validation.
Solid understanding of GxP regulatory requirements, including data integrity principles.
Demonstrated ability to develop and maintain validation documentation for complex systems.
Strong communication and problem-solving skills.
Experience with manufacturing, laboratory, and quality management systems.