Mechanical QAQC Inspection Engineer
On-siteLimerick, Munster, Ireland
Job Summary
Lead QA activities across pharma and construction projects, ensuring compliance with GMP, GEP, ISO standards, and other applicable regulations. Develop, implement, and maintain Quality Management Systems (QMS) to ensure adherence to project, client, and regulatory requirements. Oversee mechanical system installations, including HVAC, piping, and pressure vessels, with a focus on quality and compliance in both cleanroom and construction environments. Coordinate with multidisciplinary teams including engineering, validation, commissioning, construction, and operations to align quality standards. Perform supplier and contractor audits, review quality documentation, and ensure proper IQ/OQ/PQ protocols are followed. Lead Non-Conformance (NC) investigations, CAPAs, and root cause analysis for deviations. Serve as the primary quality interface with regulatory bodies and client auditors. Bachelor's degree in Mechanical Engineering with 3-5 years in Pharma and 3+ years in Construction required. Apply directly or email CV to careers@fohntechgroup.com.
Required Qualifications
- Bachelor's degree (or higher) in Mechanical Engineering
- QA experience, with at least 3-5 years in Pharma (GMP environment) and 3+ years in Construction/Infrastructure
- Solid understanding of mechanical systems within GMP manufacturing and industrial construction
- Hands-on experience with validation, commissioning, and qualification processes
- Strong familiarity with regulatory standards such as FDA, EMA, MHRA, and ISO 9001
- Experience implementing or working with QMS platforms (e.g., TrackWise, MasterControl)
- Proven experience in managing teams and leading cross-functional quality initiatives
- Excellent written and verbal communication, reporting, and stakeholder management skills
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