Package:
1. 12 Month Fixed Term Maternity Leave Contract
2. €30k – €35k Basic (Dependent on Experience & Open to Negotiation)
3. Contract Completion Bonus
4. Parking
5. Canteen
6. Paid Annual Leave
Role:
The facilities include purpose built environmentally controlled areas and cleanrooms that are temperature and humidity monitored to maximise the quality and shelf life of the product. Custom designed high output machines are used in the manufacturing process.
Duties:
7. Providing microbiological support to the site
8. Carrying out investigations on product failures and customer complaints, reporting Non-Conformities and Out of Spec Results to the Quality Control Manager and Production Manager
9. Ensuring QC meets current Manufacturing Practice (cGMP) requirements
10. Develop, maintain, update and issue microbiological methods, specifications and SOP’s in compliance quality and regulatory requirements
11. Audit and review microbiology test results on a daily/monthly/annual basis to ensure compliance with cGMP
12. Testing of QC samples provided by the Production facility to ensure compliance with specifications: e.g., product sterility, pH, Growth promotion recovery, appearance, uniformity, gel strength
13. Calibration, maintenance and operation of lab instrumentation, including: pH meter, Spiral plater, Colony counter and Turbidometer
14. Record control and documentation of work performed using laboratory worksheets
15. Maintenance of controlled organisms (ATCC and NCTC strains)
16. Additional routine tests to include environmental monitoring of controlled areas, process water (bio burden & conductivity) product shelf-life validation temperature monitoring of controlled areas
17. Performing routine laboratory maintenance tasks including organization and cleaning of work areas, waste disposal etc
Experience:
18. Degree in Microbiology or related science discipline
19. Working knowledge of cGMP and ISO standards relevant to Quality Control procedures, documentation, and testing (Min of 2 Years)
20. Experience of ISO17025 an advantage
21. Excellent, proven communication skills, both written and verbal with previous experience in drafting and maintaining process document an advantage.