Senior Consultant, Quality Compliance & Data Integrity

United Pharma; Greenville (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

United Pharma in Greenville, NC seeks experienced Senior Consultants to support a pharmaceutical client, focusing on retrospective Data Integrity review, Sterility Assurance, and GMP Quality within sterile products manufacturing.

Responsibilities include reviewing GMP documentation, ALCOA+, FDA 483 remediation, deviations and CAPAs; documenting findings in inspection-ready format and supporting investigations.

Qualifications

• 6+ years of pharmaceutical/GMP experience.
• Expertise in Data Integrity, GMP Quality Compliance, and Sterility Assurance.
• Experience with retrospective data reviews and FDA remediation.
• Knowledge of ALCOA+, 21 CFR Part 11, GMP documentation, deviations, investigations, and CAPAs.
• Experience supporting FDA inspections, Form 483 responses, or remediation.

Responsibilities

• Conduct retrospective review of GMP documentation and historical data processes.
• Assess records and data against ALCOA+, FDA cGMP, and Data Integrity requirements.
• Identify data integrity, GMP, and compliance gaps and assess impact on product quality, GMP compliance, and sterility assurance.
• Review batch records, deviations, CAPAs, environmental monitoring, microbiology, validation/qualification, and computerized system records.
• Support investigations, root cause analysis, impact assessments, and remediation activities related to FDA 483 observations.
• Document findings, rationale, and recommendations in an inspection-ready format.

Skills

Data Integrity

GMP Quality

Sterility Assurance

Retrospective reviews

FDA remediation

CAPA investigations

ALCOA+

21 CFR Part 11

Job description

We are seeking experienced Senior Consultants to support a pharmaceutical client in Greenville, NC, with a primary focus on retrospective Data Integrity review, Sterility Assurance, and GMP Quality within sterile products' manufacturing.

Key Responsibilities

• Conduct comprehensive retrospective review of GMP documentation and historical data processes, and associated validation/qualification records.
• Assess records and data against ALCOA+, FDA cGMP, and Data Integrity requirements.
• Identify potential data integrity, GMP, and compliance gaps and assess their potential impact on product quality, GMP compliance, and sterility assurance.
• Review relevant batch records, deviations, CAPAs, environmental monitoring, microbiology, validation/qualification, and computerized system records.
• Support investigations, root cause analysis, impact assessments, and remediation activities related to the FDA 483 observations.
• Clearly document findings, rationale, and recommendations in an inspection-ready format.
• Demonstrated experience supporting Sterility Assurance and GMP Quality activities within

Required Experience

• 6+ years of pharmaceutical/GMP experience, preferably in sterile manufacturing.
• Strong expertise in Data Integrity, GMP Quality Compliance, and Sterility Assurance.
• Proven experience with retrospective data reviews and FDA remediation.
• Strong understanding of ALCOA+, 21 CFR Part 11, GMP documentation, deviations, investigations, and CAPA.
• Previous experience supporting an FDA inspection, Form 483 response, or remediation.