Package:
1. Full Time / Perm Role
2. €50k – €55k+ (Basic) Negotiable
3. Annual Bonus (5%)
4. Pension
5. Life Assurance
6. Disability Benefits
7. Paid Annual Leave
8. Parking
Role:
Prepare and implement plans both long and short term for your area of responsibility in line with the company's defined strategy and agreed financial targets.
Duties:
Maintain accreditation under ISO17025:
9. Manage the Quality Management Systems and SOP's for the laboratory ensuring the requirements of ISO 17025 are implemented, maintained and complied with
10. Management of Quality Control Laboratory work planning to ensure all samples are tested in a timely fashion
People & Stakeholder Management:
11. Schedule, co-ordinate and supervise all testing within the QC laboratory ensuring that all testing is carried out in a timely fashion to meet company objectives and relevant KPIs
12. Supervise and develop the core QC Lab team by mentoring, training, and supporting personnel development plans, including allocate daily tasks for all QC lab personnel, staff issues, allocation of holidays, delegation of extended working hours when required, and in conjunction with company management policy and requirements
13. Represent the QC laboratory with support of the Quality department in regulatory and customer audits and coordinate the timely close out of NC actions / recommendations identified from relevant audits
14. Develop, maintain, and ensure implementation of in-house documents e.g. Standard Operating Procedures, Validation Protocols, Risk Assessments, technical files
15. Maintain GLP compliance in the QC laboratory
16. Oversee QC SOP's updates, change controls, deviations, CAPA's and Laboratory investigations.
17. Review and ensure application of relevant standards relating to product testing and laboratory compliance
18. Perform product/batch release following review and verification of test results to ensure product/batch compliance
19. Ensure publication of batch certs of analysis on the website when testing is complete, and results confirmed compliant
20. Co-ordinate and supervise laboratory investigations to ensure they are captured, documented, and actioned upon within a timely manner
21. Ensure the implementation of appropriate corrective and preventative actions as deemed necessary following Quality team review
22. Review and trend lab generated data to ensure continual improvement
23. Support the Quality Department with preparation for Laboratory Management Review and Quality Control meetings
24. Mediate between the testing personnel and all other departments
25. Perform and facilitate/lead internal audits, regulatory audits, supplier audits, and customer audits
26. Support management and completion of site audit schedule.
27. Lead communication with customers regarding technical queries
28. Support raw material and supplier performance reviews
29. Coordinate equipment calibration, maintenance and qualification to the predetermined schedule
30. Maintain lab consumables to ensure continuous supply and no impact on testing
31. Ensure competency and EQA testing-pH and WASP is performed
32. Arrange and support training, continual improvement and supervision of test personnel
33. Provide technical support to QA and Production functions and customers when requested
34. Advise, facilitate, and implement systems to ensure continuous improvement of processes and services
35. Ensure test method and equipment validations are completed on time
Experience:
36. 3rd Level Qualification in Engineering/Science
37. 5-8 Years of Experience in Regulated Manufacturing – Medical Device, Pharma, Biotechnology, Life Science
38. 5-8 Years Plus in a QC Laboratory environment
39. 2-5 Year Management, Supervisor experience
40. Working knowledge of ISO 17025 Working knowledge of IVDD 98/79/EC and/or IVDR (EU) 2017/746