What are the responsibilities and job description for the CSV / Data Integrity (DI) Consultant - Hybrid Framingham onsite 1x per week position at Ehub Global Inc?
Title: CSV / Data Integrity (DI) Consultant
Location: Hybrid Framingham onsite 1x per week
Duration: 12m
Role Summary:
We are seeking a proficient CSV and DI Consultant to lead data integrity initiatives and validation efforts for complex computerized systems. This role focuses on ensuring regulatory compliance, data integrity alignment, and effective collaboration across manufacturing, laboratory, and quality management domains.
Responsibilities:
- Lead Data Integrity Assessments for systems across manufacturing, laboratory, and quality processes, identifying risks and implementing control measures.
- Develop Data Process Maps, Risk Assessments, and Audit Trail Review methodologies for computerized systems.
- Update and maintain SOPs, including Validation Master Plans and sub-VMPs, to reflect compliance with regulatory standards and data integrity requirements.
- Perform and document periodic reviews of systems, incorporating findings from data integrity evaluations and ensuring alignment with validation principles.
- Provide oversight and recommendations for data reconciliation processes to resolve anomalies effectively.
- Collaborate with cross-functional teams to support system implementations, focusing on validation, data integrity, and compliance requirements.
- Conduct regular management briefings to present findings, highlight critical issues, and recommend interim control measures as needed.
- Offer QAV support to ensure systems remain compliant and audit ready.
Qualifications:
- Strong experience in CSV and data integrity compliance for manufacturing, laboratory, and quality systems.
- Expertise in regulatory requirements for data integrity, including FDA, EU Annex 11, and ALCOA principles.
- Proven ability to develop and maintain SOPs, validation plans, and risk assessments.
- Excellent analytical, documentation, and stakeholder management skills.
Familiarity with a broad range of computerized systems supporting manufacturing and laboratory processes
