Job Description
My client a leading Multinational Pharmaceutical company now require a QA Validation Specialist - Biologics MES to join their expanding team.
The QA Validation Specialist - Biologics is responsible for the coordination of validation activities principally related to a Biologics facility and ensuring compliance with current regulatory requirements. The Validation Specialist will have specific and varying duties as assigned by the Quality Systems and Compliance Manager
This is a permanent role based in Dublin.
Responsibilities of QA Validation Specialist - Biologics
? Provide validation expertise in the Production area ensuring compliance with current industry regulations, guidelines and trends.
? Coordinate execution of validation activities including the following:
? Qualification of premises, equipment and utilities.
? Including aseptic processing systems oversight (media fill, VHP validation, Environmental Monitoring)
? Computer system qualification.
? Laboratory equipment validation.
? Process validation and cleaning validation.
? Participate in cross functional project teams and assist in determining project schedules and appropriate levels of validation.
? Provide validation position on related topics and strategy and prioritise qualification activities in line with the project schedules.
? Responsible for preparation, review and approval of validation protocols, reports, procedures, deviations, change controls and other related documents to ensure compliance to internal procedures and regulatory requirements.
? Act as a subject matter expert in process validation which will be performed against global corporate SOP/HPRA /FDA/EMEA requirements.
? Execute and document process risk assessment / failure mode and effects analysis.
? Ensure GMP compliance for validation deliverables related to site and capital projects (Compliance, Improvement, Technology Transfers, etc.) including requirements definition, specification, qualification, process validation and change management.
? Provide validation expertise and support for the development (or modification phases) of manufacturing facility, equipment/systems, Material Qualification, Process Validation and Automated System and Computerized System.
? Approve and support the definition of the process development strategies and ensure linkage with PPQ strategy deployment.
? Provide support during internal and agency inspections, Annual Product Quality Review and performing quality assessment for engineering changes.
? Prepare and maintain Validation Master Plans.
? Participate in other projects as directed by the Quality Systems & Compliance Manager.
Requirements of QA Validation Specialist - Biologics
? 7 years working within quality in the pharmaceutical industry.
? A minimum of 4 years validation experience.
? Experience of sterile manufacture is essential.
? Experience of biologics manufacture is desirable.
? Experience working with ATMP is desirable.
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below