Engineering Compliance Officer - Secondment Until 31/12/2023 at Norgine | Torre

Engineering Compliance Officer - Secondment Until 31/12/2023

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Full-time

USD75.4K - 100K/year

~COP150M - 200M/year

+ Equity

+ Bonuses

location_on
Hengoed, Wales, United Kingdom
Posted about 3 years ago

Responsibilities


This company is involved in the manufacturing and supply department, ensuring compliance of the Engineering Maintenance Management Systems (EMMS). They meet FDA, MHRA & ISO 134845 - Medical Device requirements. The job purpose is to ensure compliance of the Engineering Maintenance Management Systems (EMMS) to ensure all planned, unplanned and reactive maintenance events are compliant and deputise for Compliance colleagues where required. The candidate will be responsible for EMMS system, by reviewing, approving and filing of Engineering Works Orders in line with approved SOP`s. They will also support QA and Engineering department (Site Services & Maintenance Sections) on QMS investigations and countermeasures where required. Responsibilities: - Support Site Services & Engineering department (Site Services & Maintenance Section) compliance activities to meet FDA, MHRA & ISO 134845 - Medical Device requirements. - Responsible for EMMS system, by reviewing, approving and filing of Engineering Works Orders in line with approved SOP`s. - Administration for issuing of Engineering Works Orders to schedule. - Develop KPI`s for all listed above and report on a monthly basis. - EMMS progress versus plan. - Open / Closed Scheduled Maintenance works orders by month. - Open / Closed Unscheduled Maintenance EWO by month. - BOP progress by month. - Progress on Engineering Maintenance Strategy and relevant SOP`s / Engineering Task Lists. - Completion of all Calibration / Compliance planned events. - To support QA and Engineering department (Site Services & Maintenance Sections) on QMS investigations and countermeasures where required.