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.
Key Responsibilities
* 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 (e.g., HVAC, piping, 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 (in pharma).
* Lead Non -Conformance (NC) investigations, CAPAs, and root cause analysis for deviations in construction or pharma environments.
* Ensure all materials, equipment, and systems used in construction or manufacturing are installed and qualified to meet regulatory expectations.
* Participate in project planning, risk assessments, and quality reviews from design through handover phases.
* Serve as the primary quality interface with regulatory bodies and client auditors.
Required Qualifications & Experience
o Bachelor's degree (or higher) in Mechanical Engineering.
o 7+ years of QA experience, with at least 3 -5 years in Pharma (GMP environment) and 3+ years in Construction/Infrastructure.
o Solid understanding of mechanical systems within GMP manufacturing and industrial construction.
o Hands -on experience with validation, commissioning, and qualification processes.
o Strong familiarity with regulatory standards such as FDA, EMA, MHRA, and ISO 9001.
o Experience implementing or working with QMS platforms (e.g., TrackWise, MasterControl).
o Proven experience in managing teams and leading cross -functional quality initiatives.
o Excellent written and verbal communication, reporting, and stakeholder management skills.
Next Steps
If you are interested in this role, please apply directly or email your CV to ;\/a>