The purpose of this role is to be the company's expert on the application and practice of microbial assurance as applied to the design, manufacture and sterilisation of implants while ensuring that the company meets all Corporate, FDA, Department of Health & Medical Device Directive and European Standards requirements.
MAIN DUTIES & RESPONSIBILITIES:
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 analyze 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. Work with counterparts across Sterilization to develop and implement harmonized practices/procedures
17. Develop and implement Quality planning as directed to demonstrate and realize a continual improvement in product and service e.g. WW CAPA.
18. Lead trouble shooting for product/process non-conformances OOS test results, failure investigations, and providing resolution to issues via robust CAPA
19. Working in conjunction with R&D, document and maintain in good order all relevant Quality Assurance sections of Device Development History File
20. Ensure compliance with all Documented Quality system, FDA QSR's and ISO 9001 requirements during day to day and assigned audit/CAPA activities
21. Actively support all defined Plant goals and objectives.
22. All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.
QUALIFICATIONS & EXPERIENCE
Ø Degree level qualification in Microbiology or equivalent
Ø Minimum 5 years post qualification experience as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry.
Ø Familiarity with microbiological aspects of GMP regarding sterile medical devices.
Ø Proven ability to successfully manage new product development in the Medical Device Industry. Proven knowledge and ability regarding product verification and process validations.
Ø Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
Ø ISO 9001 Lead Assessor qualification.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.