Job Description

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 Framework

• Maintain the site Data Governance Framework and data classification.
• Support implementation of data lifecycle controls.

• Data Integrity Policies & Procedures

• Support 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 Oversight

• Monitor compliance of GMP records with ALCOA++ principles.
• Identify, trend, and escalate data integrity gaps.

• Data Integrity Risk Assessment

• Conduct periodic DI risk assessments and document outcomes.
• Follow up on mitigation actions and verify control effectiveness.

• Data Integrity Auditing

• Participate in DI audits for paper and electronic systems.
• Review documentation practices, access controls, and audit trails.

• Training & Awareness

• Support DI training programs and evaluate effectiveness.
• Promote a strong data integrity culture across departments.

Requirements

• 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