Make your mark for patients
To strengthen our Microbiology Lab and Environmental Monitoring team, we are looking for a talented colleague to fill the position of: Quality Control Microbio Lab & Environmental Monitoring Specialist – Braine L’Alleud .
About the role:
The scope of the position is to support the different investigations in link with microbiology and environmental monitoring site activities: clean utilities, bioburden, endotoxins and sterility samples, environmental monitoring,…
To be the point of contact for stakeholders to support deviation/investigation in case of microbial contamination during critical manufacturing.
High level the expectations are:
1. Write report of investigations and deviations.
2. Guide investigations for quality control microbio lab & environmental monitoring.
3. To provide support to stakeholders in case of contamination.
4. To support product launches.
5. Handle actions, deviations and realize investigations within the laboratory in close partnership with team leads and quality assurance team member.
6. To smoothly communicate internally within the quality control lab team urgencies and priorities asked by different stakeholders to adjust the planning with the Team Lead.
Support Team Lead Microbio Lab and Team Lead Environmental Monitoring to write Environmental Monitoring report and suitability or study report.
You will work with:
You will report to the Head of laboratory. You will work in close partnership with lab and production team leaders, scientist and technicians/operators.
What you will do:
Support Good Manufacturing Practice activities in the laboratory such as:
7. Reports redaction.
8. Deviation/investigation lead and follow-up.
9. Change control creation and follow-up.
10. Actions follow-up.
11. Update/review of laboratory documentation: analytical methods; analytical instructions; coaching’s modules,…
12. Ensure follow-up and compliance of procedures and instructions, and update if needed.
13. Ensure follow-up of corrective actions and preventive actions.
14. Support product launches and prepare documentation requested by authorities.
15. Update of batches documentation according to specifications.
16. Support documentation linked to in process analyses.
Interested? For this position you’ll need the following education, experience and skills:
17. Minimum Master’s degree.
18. Ideally minimum 3 years industrial experience.
19. Experienced in deviation management.
20. Experienced in Microbiology and/or Environmental Monitoring.
21. Knowledge of the following techniques are an asset: endotoxins, sterility tests,…
22. Fluent in both French and English.
23. Time management.
24. Good communicator.
25. Team player.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!