cGxPServe
Roles & Responsibilities
5 to 6 years of experience in medical devices or diagnostic equipment manufacturing. Manage the end-to-end validation documentation lifecycle, including authoring, reviewing, and approving protocols (URS, IQ, OQ, PQ, PV, TMV, RTM, VSR), Change Controls, and Periodic Reviews, ensuring alignment with site VMP and ISO 13485. Lead cross-functional validation initiatives for lab equipment, facilities, and non-product software supporting molecular diagnostics platforms. Qualify GXP equipment in compliance with FDA 21 CFR Part 11 and 211. Support the entire equipment lifecycle from qualification to decommissioning. Collaborate with QA and manufacturing teams to conduct deviation management and QI/CAPA investigations, executing root cause analysis (e.g., 5 Whys, Fishbone). Apply statistical tools (ANSI/ASQ Z1.4 sampling plan) and techniques such as Normality tests, Distribution analysis, and control charts to support method validation, trending, and process robustness. Utilize GAMP5 risk-based validation framework for assessing and validating non-product software systems used in quality and manufacturing environments; author NPSW documentation. Drive agile change control processes for the release of agile production documents. Interface with View Linc and Vaisala systems to obtain environmental monitoring data for validation and QMS purposes. Conduct gap analyses on method validation processes, environmental monitoring, and equipment qualification, aligning with industry and regulatory standards. Support VRB meetings, document validation metrics, track goals, and escalate issues for resolution.
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5 to 6 years of experience in medical devices or diagnostic equipment manufacturing. Manage the end-to-end validation documentation lifecycle, including authoring, reviewing, and approving protocols (URS, IQ, OQ, PQ, PV, TMV, RTM, VSR), Change Controls, and Periodic Reviews, ensuring alignment with site VMP and ISO 13485. Lead cross-functional validation initiatives for lab equipment, facilities, and non-product software supporting molecular diagnostics platforms. Qualify GXP equipment in compliance with FDA 21 CFR Part 11 and 211. Support the entire equipment lifecycle from qualification to decommissioning. Collaborate with QA and manufacturing teams to conduct deviation management and QI/CAPA investigations, executing root cause analysis (e.g., 5 Whys, Fishbone). Apply statistical tools (ANSI/ASQ Z1.4 sampling plan) and techniques such as Normality tests, Distribution analysis, and control charts to support method validation, trending, and process robustness. Utilize GAMP5 risk-based validation framework for assessing and validating non-product software systems used in quality and manufacturing environments; author NPSW documentation. Drive agile change control processes for the release of agile production documents. Interface with View Linc and Vaisala systems to obtain environmental monitoring data for validation and QMS purposes. Conduct gap analyses on method validation processes, environmental monitoring, and equipment qualification, aligning with industry and regulatory standards. Support VRB meetings, document validation metrics, track goals, and escalate issues for resolution.
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