Summary
A QA Validation Specialist is required for a biopharmaceutical company in Dunboyne. The successful candidate will support new commissioning and validation programmes across the site and lead periodic reviews of validated systems in Drug Substance, Facilities, and Laboratories to ensure ongoing cGLP and cGMP compliance.
Responsibilities
Collaborate with project-based teams, Validation, Microbiology, IT, Engineering utilities and other departments to provide QA support for commissioning, decommissioning and Validation project across site.
Responsible for the approval of Validation Lifecycle documents and reports supporting the introduction of new laboratory and process equipment.
Responsible for the approval of Validation Lifecycle documents and reports supporting Temperature mapping, EMPQ and AVS studies.
Provide Quality oversight of Periodic review and Equipment revalidation.
Provide real time review of commissioning test scripts and elevate issues in a timely manner to CQV and QA leadership as appropriate.
Support the Site Calibration program.
Act as Quality Assurance point of contact for Cleaning Validation, WFI PQ, and PQ of process equipment including Filter Integrity, parts washers, Autoclaves and process Validation studies, etc.
Act as a Champion for developing a Data Integrity Culture across site.
Working Knowledge of GMP regulatory guidelines with the ability to accurately interpret, and provide quality guidance for validation activities in the drug substance and laboratory areas.
Any other tasks as directed by QA Validation Lead.
Qualifications & Experience
Min of a BSc Degree in relevant Science. MSc preferable.
Min. 1 year Validation / CQV experience.
Experience in a Pharma / Biopharmaceutical GMP setting.
Knowledge of cGMP Process & utility Quality Systems would be an advantage.
Knowledge of Deviation management, Change Management, Risk Management would be an advantage.
KNEAT, Cleaning Validation, Environmental Monitoring, Filter Validation studies and Single use equipment as distinct advantage.
Knowledge of regulatory guidelines supporting Drug substance manufacturing: ICH, EU and FDA would be an advantage.
Strong technical writing skills required would be an advantage.
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