Senior Data Integrity & GMP Compliance Consultant

Hyper Recruitment Solutions Ltd; North Carolina; Hybrid; USD 110,000 - 150,000; Full time

Job summary

Hyper Recruitment Solutions Ltd is seeking a Senior Consultant, Quality Compliance & Data Integrity to join a leading pharmaceutical manufacturing organization in North Carolina. The role focuses on retrospective data integrity reviews for sterile products, ensuring robust compliance with GMP and ALCOA+ standards.

You will review qualification and validation documentation, identify data integrity gaps, and support FDA remediation efforts.

Qualifications

• Degree or higher in Pharmaceutical Science, QA, or Quality Management.
• Extensive pharma/GMP experience, preferably in sterile manufacturing.
• Strong data integrity and quality compliance expertise.
• Knowledge of ALCOA+, 21 CFR Part 11, CAPA.

Responsibilities

• Conduct retrospective GMP documentation and data reviews.
• Review qualification and validation docs for equipment, systems, utilities.
• Evaluate records per ALCOA+, FDA cGMP, and Data Integrity.
• Support investigations, root cause analysis, and remediation.

Skills

Data Integrity

ALCOA+

FDA 21 CFR Part 11

GMP

CAPA

FDA remediation

Retrospective data reviews

Quality Compliance

Education

Bachelor's degree in Pharmaceutical Science/QA/Quality Management

Job description

Hyper Recruitment Solutions Ltd is seeking a Senior Consultant, Quality Compliance & Data Integrity to join a leading pharmaceutical manufacturing organization in North Carolina. The role focuses on retrospective data integrity reviews for sterile products, ensuring robust compliance with GMP and ALCOA+ standards.

You will review qualification and validation documentation, identify data integrity gaps, and support FDA remediation efforts.