We have an exciting opportunity for a Compliance Engineer to join Norgine.
Core Responsibilities
This role is to ensure that products, systems, and processes adhere to applicable safety, quality, and regulatory standards. Responsibilities include conducting inspections, performing tests, analyzing data to identify non-compliance, and implementing corrective actions. The role also involves ensuring compliance of the site calibration process, controlling the Engineering Maintenance Management Systems (EMMS), and deputizing for the Compliance Team Leader when required.
* Carry out calibration works across all relevant machines and processes, investigating issues and correcting problems.
* Perform hands-on fault finding, documenting and reporting root cause analysis, and implementing countermeasures in line with QMS procedures.
* Manage the EMMS system by reviewing, approving, and filing Engineering Works Orders according to SOPs.
* Supervise administration support for issuing Engineering Works Orders to schedule maintenance activities.
* Manage the Engineering Task List (ETL) process to ensure compliance at all times.
* Review current SOPs and develop a suite of SOPs detailing the site engineering maintenance strategy, aligned with EMMS and ISPE guides.
* Support QA and Engineering departments on QMS investigations and countermeasures as needed.
* Participate in QA internal audits and support continuous review and improvement of calibration and maintenance procedures.
* Develop risk analyses of current maintenance and calibration methods to enhance efficiency and compliance.
* Support other activities within QA and Engineering departments as required.
Health, Safety, and GMP
* Maintain tools and equipment in a safe working condition and ensure the workshop and plant rooms are safe environments.
* Adhere to technical procedures and GMP standards.
* Work in a clean, orderly manner following the company's hygiene policies.
* Ensure all health and safety standards are met and equipment complies with legal standards.
Miscellaneous
* Ensure timely completion of work orders.
* Liaise effectively with external contractors.
* Willing to learn new skills and train others as needed.
* Represent the Engineering Department in production meetings and maintain effective communication within the team.
* Develop and maintain good working relationships with production managers.
* Present a professional image and act positively at all times.
* Support the company's vision, goals, and targets.
* Communicate effectively and build relationships.
* Act decisively to ensure high standards of health, safety, quality, and compliance.
* Respond promptly to emergencies and disruptions.
* Monitor performance metrics, diagnose faults, and implement corrective actions.
* Support compliance activities related to FDA, MHRA, and ISO 13485 standards.
* Oversee and manage all systems involving calibrations, maintenance, and document review.
We seek a proactive individual with a commitment to continuous improvement, excellent decision-making skills, and the ability to work independently and as part of a team. Effective communication, computer literacy, and understanding of electrical and mechanical drawings are essential.
Our benefits vary per location; please contact the Norgine TA representative for more details.
At Norgine, we foster a culture of innovation, development, and community. We offer a 3D career experience—Dare, Drive, Develop—where you can bring your authentic self, pursue growth, and make a difference through healthcare solutions.
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