Senior Consultant Quality DI Review - Qualification Documentation and Process Equipment Focus. at United Pharma Senior Consultant Quality DI Review - Qualification Documentation and Process Equipment Focus. at United Pharma in Colfax, North Carolina Posted in about 12 hours ago.

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full-time 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. Including URS, IQ, OQ, PQ, commissioning documentation, protocols, reports, deviations, 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 manufacturing, including equipment qualification records, operating parameters, alarms, 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 activities