The QA Systems & Validation Specialist will be responsible for ensuring the quality of systems and processes at SK biotek Ireland's Swords Campus. This 12-month contract role reports directly to the Quality Manager.
Key Responsibilities:
* Audit and assess changes for GMP compliance in accordance with site change control procedures.
* Review and approve qualification and validation protocols, summary reports, and associated data to ensure conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
This includes:
* Qualification of premises, equipment, and utilities.
* Computer system qualification.
* Laboratory equipment validation.
The successful candidate will provide expertise in validation, ensuring compliance with current industry regulations, guidelines, and trends. They will also participate in cross-functional project teams as the quality assurance validation representative.
Responsibilities include reviewing and approving the GMP design aspects of major capital projects, communicating with departments on site to ensure timely approval of change controls, and ensuring all quality systems are implemented/executed in compliance with ICH Q7, Eudralex, 21 CFR, and site Quality standards.
Requirements:
* Minimum BSc/BEng in Chemistry, Engineering, or a science-related discipline with at least 3 years pharmaceutical experience, preferably in a QA role.
* Knowledge/appreciation of other site operations, such as QC, Operations, Engineering, and IT.
* Experience in Operational Excellence or project management is desirable.
* Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.