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

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.

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Key Responsibilities

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∙Conduct comprehensive retrospective review of GMP documentation and historical data .

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∙Review and assess qualification and validation documentation for manufacturing

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equipment, systems, utilities, processes, and associated validation/qualification records.

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Including URS, IQ, OQ, PQ, commissioning documentation, protocols, reports, deviations,

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and associated change controls, to determine whether equipment and processes were

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appropriately qualified and remain in a validated state.

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∙Assess records and data against ALCOA+, FDA cGMP, and Data Integrity requirements .

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∙Identify potential data integrity, GMP, and compliance gaps and assess their potential impact

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on product quality and sterility assurance .

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∙Review relevant batch records, deviations, CAPAs, environmental monitoring, microbiology,

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validation/qualification, and computerized system records.

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∙Support investigations, root cause analysis, impact assessments, and remediation activities

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related to the FDA 483 observations.

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∙Clearly document findings, rationale, and recommendations in an inspection-ready format .

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∙Evaluate process equipment and manufacturing systems used in sterile product

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manufacturing, including equipment qualification records, operating parameters, alarms,

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controls, maintenance/calibration records, and associated procedures, and assess their

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potential impact on product quality, data integrity, and sterility assurance

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Required Experience

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∙7+ years of pharmaceutical/GMP experience , preferably in sterile manufacturing.

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∙Strong expertise in Data Integrity and Quality Compliance .

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∙Proven experience with retrospective data reviews and FDA remediation .

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∙Strong understanding of ALCOA+, 21 CFR Part 11, GMP documentation, deviations,

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investigations, and CAPA .

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∙Previous experience supporting an FDA inspection, Form 483 response, or remediation

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program is highly desirable.

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∙Experience reviewing equipment and process qualification documentation, including

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IQ/OQ/PQ and associated validation records, deviations, change controls, and requalification

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activities

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