We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
1. Assist the International Sterility Assurance Manager in coordinating the activities of a defined team of QA Micro personnel.
2. Supervisory responsibilities include day to day work allocation and prioritization, coaching, training, contribute to performance and output quality review, internal communications and general personnel assistance during the course of their duties.
3. To be responsible for delivering the microbial assurance aspects of the Quality System.
4. To review and develop protocols/procedures for all microbial assurance activities.
5. Assist the Intl Sterility Assurance Manger & Director of Quality Operations to manage the regulatory compliance program to include FDA and BSI.
6. Work with third party regulators as required to ensure smooth running of assessments
7. Work with manufacturing and facilities to control biological portion of validation of DI Water, controlled environment and finishing systems
8. To implement the GMP training programme for clean rooms and other appropriate staff
9. Lead Microbiology on process change assessments for existing products & new product development/transfer validation
10. Ensure Cleaning and Sterilization validations are completed for all Cork products, including re-qualifications, NPRT studies, etc.
11. To be responsible for the release of sterile products.
12. To ensure regular microbial monitoring of all clean room facilities and water systems, to analyse the results and recommend corrective action where appropriate.
13. To oversee/co-ordinate site bioburden and dose audit program
14. Ensure effective and timely communications both oral and written (weekly/monthly written reports, Project updates, daily/weekly direction to Microbiology personnel).
15. To lead specific projects as allocated by the Intl Sterility Assurance Manager.
16. Develop and implement Quality planning as directed to demonstrate and realize a continual improvement in product and service e.g. WW CAPA.
17. Lead trouble shooting for product/process non-conformances OOS test results, failure investigations, and providing resolution to issues via robust CAPA
20. Working in conjunction with R&D, document and maintain in good order all relevant Quality Assurance sections of Device Development History File
Education & Experience
- Degree level qualification in Microbiology or equivalent
- Post qualification experience as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry.
- Familiarity with microbiological aspects of GMP regarding sterile medical devices.
- Proven ability to successfully manage new product development in the Medical Device Industry. - Proven knowledge and ability regarding product verification and process validations.
- Proven knowledge of FDA and MDD GMP requirements regarding Medical Devices.
- ISO 9001 Lead Assessor qualification.
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480
PLEASE APPLY DIRECTLY BY CLICKING HERE
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