QA Data Integrity Professional

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

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