QA Validation Specialist

Description

• Responsible for the approval of Validation Lifecycle documents and reports supporting the introduction of new laboratory and process equipment.
• Provide Quality oversight of Periodic review and Equipment revalidation.
• Responsible for the approval of Validation Lifecycle documents and reports supporting Temperature mapping, EMPQ and AVS studies
• Support the Site Calibration program
• 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.
• Act as a Champion for developing a Data Integrity Culture across site.
• Provide real time review of commissioning test scripts and escalate issues in a timely manner to CQV and QA leadership as appropriate.
• 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.

Requirements

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.

• Min of a BSc Degree in relevant Science. MSc preferable.
• Experience in a Pharma / Biopharmaceutical GMP setting.
• Knowledge of regulatory guidelines supporting Drug substance manufacturing: ICH, EU and FDA 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.
• 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
• Strong technical writing skills required would be an advantage.
• Min. 1 year Validation / CQV experience.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance