About the role
Join our dynamic team in APEX Pharma, as a QA Data Integrity Professional! We're seeking a passionate and experienced Data Integrity Professional within our Pharmaceutical Quality Assurance department. You'll play a crucial part in Implement and monitor Data Integrity and Data Governance practices across the site to ensure GMP data and records are reliable and inspection-ready, in line with approved SOPs, the site QMS, and ALCOA++. The role performs routine DI reviews/audits, identifies risks and gaps, recommends improvements, and escalates critical issues.Responsibilities:• Data Governance FrameworkMaintain the site Data Governance Framework and data classification.Support implementation of data lifecycle controls.• Data Integrity Policies & ProceduresSupport development and update of DI policies/SOPs in line with QMS and regulations.Ensure integration of DI requirements within GMP systems and promote best practices.• ALCOA++ Compliance OversightMonitor compliance of GMP records with ALCOA++ principles.Identify, trend, and escalate data integrity gaps.• Data Integrity Risk AssessmentConduct periodic DI risk assessments and document outcomes.Follow up on mitigation actions and verify control effectiveness.• Data Integrity AuditingParticipate in DI audits for paper and electronic systems.Review documentation practices, access controls, and audit trails.• Training & AwarenessSupport DI training programs and evaluate effectiveness.Promote a strong data integrity culture across departments.
5-8 years in pharmaceutical quality systems, data integrity, or governance roles.Bachelor’s degree in Sciences, Chemistry, Biotechnology, Pharmacy, or any other relevant.Strong knowledge of data integrity principles and practices (ALCOA++).GMP knowledge and training facilitation skills.Excellent documentation and organizational skills.Strong communication and stakeholder management abilities.Ability to work under regulatory pressure and audit conditions.Data Integrity and Governance Principles.Audit and Inspection Readiness
