Compliance Engineer

Join Norgine, a company that transforms lives with innovative healthcare solutions. As a Compliance Engineer, you will ensure products, systems, and processes adhere to applicable safety, quality, and regulatory standards. You will conduct inspections, perform tests, and analyze data to identify areas of non-compliance and implement corrective actions.

Requirements

• Carry out calibration works across all relevant machines and processes, investigating any issues and correcting the problem
• Manage EMMS system, by reviewing, approving and filing of Engineering Works Orders in line with approved SOP`s
• Supervise administration support for issuing of Engineering Works Orders to schedule
• Manage, Engineering Task List (ETL) process, ensuring ETLs are compliant at all times
• Review current SOP`s and Develop suite of SOP`s to detail the site engineering maintenance strategy in line with EMMS and ISPE guides
• Support QA and Engineering department (Site Services & Maintenance Sections) on QMS investigations and countermeasures where required
• Support QA internal audit schedule, by performing internal audits as required
• Pro-active analysis of calibration and maintenance procedures and practices, regular reviews and updates in line with relevant good practice guides and improvement opportunities
• Develop and introduce risk analysis of current maintenance and calibration methods to reduce / increase tasks to ensure an efficient and compliant maintenance and calibration system
• To support QA and Engineering department (Site Services & Maintenance Sections) on other activities as directed when required

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance