Job title: Quality Auditor
Working model: On-Site
Location: Carlow
Pay rate: 30+ EUR/hourly on Fixed-Term Contract
Duration: Dec-2025
Job Responsibilities:
The Quality Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure compliance with SOPs and GMPs and worldwide regulations. Responsibilities include:
1. Review and approve production and analytical documentation accompanying the release of API, Safety Assessment, or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
2. Communicate and resolve audit comments with client areas.
3. Perform audits or inspections of assigned areas or systems under supervision or as part of a team to assess compliance with regulatory and Company standards.
4. Issue reports summarizing deficiencies and work with areas to execute remedial action.
5. Notify appropriate management of inspection results.
Works with moderate work direction and is skilled and knowledgeable in the position.
Qualifications:
Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations. Effective communication (oral/written) and interpersonal skills are necessary.
The Client needs someone with Quality oversight experience in reviewing and approving documents associated with Equipment Validation, Cleaning validation, Sterilization such as Autoclaves and other equipment like CTUs, Isolators etc. Additionally, experience in Quality oversight of equipment Qualification and the ability to review and approve the following documents: IQ, OQ, PQ, IOC, IOQ's etc. Familiarity with systems such as Kneat, IPI, and Veeva Vault would be advantageous.
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