Senior Consultant Quality DI Review - Qualification Documentation and Process Equipment Focus.

United Pharma; Greensboro (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

United Pharma in Greensboro, NC seeks an experienced Senior Consultant to support a pharmaceutical client in Greenville, NC, focusing on retrospective data integrity review for sterile product manufacturing. You will perform retrospective GMP data reviews, assess qualification/validation documentation, and identify data integrity gaps aligned with ALCOA+ and 21 CFR Part 11.

Responsibilities include supporting FDA 483 remediation efforts, investigations, root cause analysis, and preparing

Qualifications

• 7+ years of pharmaceutical/GMP experience, preferably in sterile manufacturing.
• Strong expertise in Data Integrity and Quality Compliance.
• 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 program is highly desirable.
• Experience reviewing equipment and process qualification documentation, including IQ/OQ/PQ and associated validation records, deviations, change controls, and requalification.

Responsibilities

• Conduct retrospective review of GMP documentation and historical data.
• Review and assess qualification and validation documentation for equipment, systems, utilities, processes, and related change controls.
• Assess records against ALCOA+, FDA cGMP, and Data Integrity requirements.
• Identify data integrity, GMP, and compliance gaps and assess their impact on product quality and sterility.
• Review batch records, deviations, CAPAs, environmental monitoring, microbiology, validation/qualification, and computerised system records.
• Support investigations, root cause analysis, impact assessments, and remediation related to FDA 483 observations.
• Document findings and recommendations in an inspection-ready format.
• Evaluate process equipment and manufacturing systems affecting sterile product controls and calibration records.

Skills

Data Integrity

Quality Compliance

ALCOA+

21 CFR Part 11

GMP Documentation

CAPA

Deviations

Investigations

FDA remediation

Tools

IQ/OQ/PQ

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 for sterile products’ manufacturing.

Key Responsibilities

• Conduct comprehensive retrospective review of GMP documentation and historical data.
• Review and assess qualification and validation documentation for manufacturing equipment, systems, utilities, processes, and associated validation/qualification records and associated change controls, to determine whether equipment and processes were appropriately qualified and remain in a validated state.
• 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 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.
• Evaluate process equipment and manufacturing systems used in sterile product controls, maintenance/calibration records, and associated procedures, and assess their potential impact on product quality, data integrity, and sterility assurance.

Required Experience

• 7+ years of pharmaceutical/GMP experience, preferably in sterile manufacturing.
• Strong expertise in Data Integrity and Quality Compliance.
• 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 program is highly desirable.
• Experience reviewing equipment and process qualification documentation, including IQ/OQ/PQ and associated validation records, deviations, change controls, and requalification