Commissioning, Qualification & Validation Consultant (12 month contract) Industry: Pharmaceutical
Department: QA Validation, Large Equipment
Role Summary: The role of the Commissioning, Qualification & Validation Consultant contractor is to implement policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
Essential Duties and Responsibilities include but are not limited to the following:
Generates, executes, reviews qualifications and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Analyses the results of testing and determines the acceptability of results against pre-determined criteria. Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements. Co-ordinates with cross functions for interdependent tasks, decision making, timely escalations on quality events/project delays, safety, etc. Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions. Coordinates with other departments or outside contractors/vendors to complete validation tasks. Capability to work as an independent contributor as well as in team tasks. Well versed with safety practices at the site. Trains/advises less experienced specialists and technicians. Assesses quality system documentation for completeness and accuracy, and dispositions documentation per client SOPs. Manages projects and prepares status reports. Familiarity with equipment on QC, manufacturing (drug substance – Especially MAbs), AHU, Facilities, utilities. Basic familiarity with paperless validation tool like ValGenesis. Working to expert level knowledge in 21CFR part 11, Computerized system, PLC/HMI/SCADA systems, Audit trail etc. Familiarity with deliverables minimum but not limited to: URS DQ, IQ, OQ, IOQ Commissioning Protocol Traceability Matrix Summary Reports Turn Over Package SOP 21 CFR part 11 assessment Data integrity assessments Protocol change controls/Deviations etc. System Life cycle documents. Education and Experience: Requires a BS/BA in Engineering, Chemistry, or Life Sciences with 8-10+ years of related experience within the field; will substitute relevant experience for education. Qualification/validation experience required. Well versed with Microsoft tools like Word, Excel, PowerPoint etc. Contract: 12 Month Contract
Location: Limerick
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