Objective: Ensure data integrity and regulatory compliance across the pharmaceutical lifecycle, supporting GMP and QC processes.
Key Responsibilities:
- Audit electronic and paper-based records for compliance with ALCOA+ principles.
- Assess data governance systems to prevent unauthorized access or manipulation.
- Collaborate with IT and QA teams for secure data management practices.
- Review laboratory practices to ensure adherence to GMP and GLP standards.
- Evaluate sampling, testing, and documentation for accuracy and regulatory compliance.
- Identify non-conformities, recommending corrective actions.
- Ensure audit readiness, supporting regulatory inspections with compliant documentation.
- Work with analysts and production teams to enhance QC processes.
Qualification:Bachelor’s degree in Pharmacy, or science 5–7 years of experience in a GMP-regulated pharmaceutical, preferably in Quality Control.Familiarity with GMP, GLP, ALCOA+, 21 CFR Part 11, EU Annex 11, and data integrity guidance.Preferred Qualifications:Experience with LIMS, or ERP systems in a regulated environment.Certification in Quality Auditing, GxP Compliance, or Data Integrity.