- JN -012024-1953849
- Jan 11, 2024
I am currently seeking a quality compliance specialist to join a pharmaceutical company based in Dublin on a permanent basis. This is an on-site role based in Dublin Northwest.
In this role you will be responsible for maintaining the ongoing compliance of the quality management systems. The successful candidate will have a 3rd level degree with 3 years' experience working in a medical device or pharmaceutical manufacturing environment. You will have an excellent working knowledge of ISO 13485, 21 CFR Part 820 and EU GMP. Exposure to auditing experience also relating to ISO 13485 is preferred. Excellent quality systems and compliance experience required.
- Provide Quality document control oversight on documentation and reports.
- Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations, and standards.
- Support Global Systems Administrator in software updates and validation relating to the system.
- Responsible for management of Systems Training - developing, scheduling, and performing.
- Responsible for management of Document Management Training on site - developing, scheduling, and performing.
- Support generation of data for Management Review.
- Management of Site Metrics generation (weekly and monthly) including reporting out Globally.
- Management of off-site Records Management Supplier.
- Responsible for managing the Process Confirmation program on site.
- Responsible for ensuring compliance to GMP review requirements to maintain compliance to customer requirements and enterprise procedures.
- Acting as compliance representative on Quality Projects within the site.
- Participation in Internal Audit Program.
- Support in preparation and hosting of Third-Party Audits including audit training and control room set up.
- QMS compliance tracking and trending of issues and patterns to drive improvements.
If this role is of interest, please 'apply now' or contact me on 021 2300 300 to discuss further.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
- Senior Consultant | Engineering Recruitment