Mechanical QA Lead

We are seeking an experienced Mechanical QA/ QC Lead with a robust background in Mechanical Engineering, and a proven track record in both the Pharmaceutical and Construction sectors. This is a unique cross -industry role requiring a deep understanding of GMP, GEP, and engineering best practices to oversee and enhance quality processes throughout the project lifecycle.
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Key Responsibilities<\/b>
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• Lead QA activities across pharma and construction projects, ensuring compliance with GMP, GEP, ISO standards, and other applicable regulations.
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• Develop, implement, and maintain Quality Management Systems (QMS) to ensure adherence to project, client, and regulatory requirements.
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• Oversee mechanical system installations (e.g., HVAC, piping, pressure vessels) with a focus on quality and compliance in both cleanroom and construction environments.
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• Coordinate with multidisciplinary teams including engineering, validation, commissioning, construction, and operations to align quality standards.
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• Perform supplier and contractor audits, review quality documentation, and ensure proper IQ/OQ/PQ protocols are followed (in pharma).
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• Lead Non -Conformance (NC) investigations, CAPAs, and root cause analysis for deviations in construction or pharma environments.
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• Ensure all materials, equipment, and systems used in construction or manufacturing are installed and qualified to meet regulatory expectations.
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• Participate in project planning, risk assessments, and quality reviews from design through handover phases.
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• Serve as the primary quality interface with regulatory bodies and client auditors.
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  Required Qualifications & Experience<\/b>
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  • Bachelor’s degree (or higher) in Mechanical Engineering.
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  • 7+ years of QA experience, with at least 3 -5 years in Pharma (GMP environment) and 3+ years in Construction/Infrastructure.
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  • Solid understanding of mechanical systems within GMP manufacturing and industrial construction.
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  • Hands -on experience with validation, commissioning, and qualification processes.
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  • Strong familiarity with regulatory standards such as FDA, EMA, MHRA, and ISO 9001.
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  • Experience implementing or working with QMS platforms (e.g., TrackWise, MasterControl).
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  • Proven experience in managing teams and leading cross -functional quality initiatives.
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  • Excellent written and verbal communication, reporting, and stakeholder management skills.
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    Next Steps<\/b>
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    If you are interested in this role, please apply directly or email your CV to careers@fohntechgroup.com<\/a>
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