QA Data Integrity Professional
Cairo
Experience الخبرة
5 To 8 Years
Career Level المستوى
Experienced (Non-Manager)
Education التعليم
Bachelor's Degree
Salary الراتب
Confidential
Skills Required المهارات المطلوبة
R&D/Science
Quality
Pharmaceutical
Quality Assurance
QA
Data Integrity
Data Governance (DG)
GMP
SOPS
Standard Operating Procedure
QMS
Quality Management System
ALCOA++
Risk Management
Pharmacy
Sciences
Chemistry
Biotechnology
Quality Assurance (QA)
Good Manufacturing Practices (GMP)
Standard Operating Procedures (SOPs)
Quality Management System (QMS)
ALCOA++ Principles
Pharmacy Practices
Scientific Principles
Chemistry Knowledge
Biotechnology Processes
Pharmaceutical Manufacturing
Auditing
CAPA
Job Description الوصف الوظيفي
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.
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Job Overview
CategoryPharmaceutical
LocationCairo
Experience5 To 8 Years
Career LevelExperienced (Non-Manager)
EducationBachelor's Degree
Posted5 days ago
