QA SME Data Integrity

Develop and maintain data integrity policies, procedures, and standards across the site. Conduct data integrity audits, reviews, and risk assessments to ensure regulatory compliance. Manage the GxP data lifecycle to ensure data is accurate, complete, secure, and traceable. Provide oversight of computerized systems to ensure compliance with regulatory requirements and validated status. Lead data integrity investigations, root cause analysis, and CAPA implementation. Identify compliance gaps and implement sustainable data integrity improvements. Support supplier audits, regulatory inspections, and maintain inspection readiness. Deliver data integrity training and provide technical guidance to promote a strong quality culture. Qualification Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, IT, Computer Science, or a related scientific field. Experience Minimum 5 years' experience in pharmaceutical manufacturing, Quality Assurance, Quality Control, Validation, or Regulatory Compliance.. Knowledge of Data Integrity, ALCOA+, GDP, GxP, ICH Q9/Q10, and FDA/EU GMP requirements is advantageous. Knowledge of computerized systems (e.g., LIMS, CDS, MES, SCADA, EDMS), knowledge of audit trails and data review requirements and understanding of validation documentation and processes related to data integrity. Strong knowledge and experience of Data Integrity Risk Assessments. Experience in and support with Regulatory inspections.