Quality & Compliance Engineer

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a Quality & Compliance Engineer to join Norgine.

The person holding this position will report to QA Compliance Section Leader.

If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.

MAIN PURPOSE:

To ensure compliance of the site Calibration process, control the Engineering Maintenance Management Systems (EMMS) to ensure all planned, unplanned and reactive maintenance events are compliant and deputise for Compliance section leader where required.

• Support QA and Engineering department (Site Services & Maintenance Section) compliance activities to meet FDA, MHRA & ISO 134845 - Medical Device requirements.
• Support external QMS audits as and when required.
• Management of the site calibration process ensuring compliance to GMP and budget.
• Responsible for investigating out of compliance calibration devices, involving hands on fault finding, documenting and reporting root cause analysis, countermeasures in line with QMS procedures.
• Manage EMMS system, by reviewing, approving and filing of Engineering Works Orders in line with approved SOP`s.
• Supervision of administration support for issuing of Engineering Works Orders to schedule.
• Pro – Active Analysis of calibration and maintenance procedures and practices, regular reviews and updates in line with relevant good practice guides and improvement opportunities.
• Review current SOP`s and Develop suite of SOP`s to detail the site engineering maintenance strategy in line with EMMS and ISPE guides.
• Manage, Engineering Task List (ETL) process, ensuring ETLs are compliant at all times.
• 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 QMS investigations and countermeasures where required.
• Support QA internal audit schedule, by performing internal audits as required.
• Lead and / or participate in Lean 6 sigma, CI, Equipment procurement and process improvement projects as requested.
• To support QA and Engineering department (Site Services & Maintenance Sections) on other activities as directed when required.

MAIN TASKS

·         Develop KPI`s for all listed above and report on a monthly basis.

• EMMS progress versus plan.
• Open / Closed Scheduled Maintenance works orders for each section by month.
• Open / Closed Unscheduled Maintenance EWO for each section by month.
• Progress on Engineering Maintenance Strategy and relevant SOP`s / Engineering Task Lists.
• Completion of all Calibration / Compliance planned events.

·         QA Compliance & Engineering Department (Site Services & Maintenance Sections) to be 100% compliant at all times.

RELATIONSHIPS:

·         Close working relationships with Site Engineering Sections Leaders:

• Site Services Supervisor.
• Maintenance Section Leader / Maintenance Shift Leaders.

·         Close working relationships with Production personnel:

• Shift Leaders / Team Leaders.

·         Close working relationships with Quality Assurance:

• QA Manager, Senior Quality Officer, Quality Officer and Quality Technical Administrator.

SKILLS & KNOWLEDGE

·       Degree in appropriate subject desirable, Minimum HNC Level or equivalent depending on experience.

·       Green belt 6 sigma level (or similar) skills and experience.

·       Prioritise own workload, using initiative and organisational ability, thus meeting all target dates.

·       A self-starter with a high degree of initiative, ability to work independently and as part of a team. Strong teamwork and interaction skills required.

·       Excellent organisational and communication skills (both oral, written and presentation).

·       Accurate with good literacy and numerical skills.

·       Awareness of Manufacturing, Packaging Engineering, Facilities and Utilities.

·       Awareness of Production and Equipment Quality requirements.

·       Understanding of Engineering Maintenance activities.

·       A knowledge and understanding of the pharmaceutical industry, with particular reference to Medical Device experience.

·       Computer literacy i.e. MS Office, MS project.

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

Sound good? Find out more about the career you’ll have with Norgine, then apply here.