QA and Data Integrity Consultant

Role Overview

We are currently looking for a Senior Consultant, Quality Compliance & Data Integrity to join a leading pharmaceutical manufacturing organization based in our client's location. This is an exciting opportunity for a seasoned professional with a passion for maintaining the highest standards in GMP environments and ensuring robust data integrity practices. In this role, you will play a pivotal part in supporting compliance and quality assurance activities, specifically focusing on retrospective Data Integrity reviews for sterile products' manufacturing. Your expertise will be essential in safeguarding product quality and sterility, contributing to industry-leading standards.

Key Duties And Responsibilities

• Conduct comprehensive retrospective reviews of GMP documentation and historical data to ensure ongoing compliance.
• Review and assess qualification and validation documentation for manufacturing equipment, systems, utilities, and associated records.
• Evaluate records and data in accordance with ALCOA+, FDA cGMP, and Data Integrity requirements.
• Identify potential data integrity, GMP, and compliance gaps, and assess their impact on product quality and sterility assurance.
• Support investigations, root cause analysis, and remediation activities related to FDA 483 observations, ensuring all findings are meticulously documented in an inspection-ready format.

Role Requirements

• A Degree or higher level in a relevant field (e.g., Pharmaceutical Science, Quality Assurance, or Quality Management).
• Extensive pharmaceutical/GMP experience, preferably within sterile manufacturing environments.
• Strong expertise in Data Integrity and Quality Compliance, with proven experience in retrospective data reviews and FDA remediation.
• Strong understanding of ALCOA+, 21 CFR Part 11, GMP documentation, deviations, investigations, and CAPA.

Benefits

• Opportunity to work within a dynamic and compliant environment, supporting critical activities in pharmaceutical manufacturing.
• Chance to influence compliance strategies, contribute to FDA remediation efforts, and make a tangible difference in ensuring product sterility and quality.
• Professional growth and an engaging environment where your expertise will genuinely make an impact.