Microbiology Expert - Seneffe, België - Thermo Fisher Scientific

Thermo Fisher Scientific

Geverifieerd bedrijf

Seneffe, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

This type of facility needs to be conformed to the rules et regulation of the BPF established by the ministers of health and the social protection of countries, as well as the international directives.

Manufacturing activities are performed in an effective and efficient way to guarantee the global competitivity of the sites.

Besides, due to the very high value of the intermediate products and products, the production activities are executed in a highly controlled way.

Take part to the business entity's growth by ensuring high value products disposition in a controlled manner Be key in processes compliance by following daily routine of the manufacturing steps and associated services while partnering and interacting with relevant key positions in departments.

Purpose:

Empower the technicians/samplers team to ensure sampling and analyses of environmental monitoring of our production areas, utilities distribution networks

Ensure that monitoring program is applied and respected:

Trend the results of production area and communicate to collaborators (production, QA)
Increase expertise by training technicians/samplers to analytical techniques as well as laboratory/sampling good practices and support troubleshooting
Lead Pharmacopoeia requirements for the environmental monitoring team (i.e., update templates, LIMS requirements and trainings documentation, support troubleshooting, review Pharmacopoeia updates vs QC practices, etc)
Coordinate all requests of analysis asked by the stakeholders, ensure the followup and communicate the results
Support projects, deviations, and investigations within the laboratory

What You'll Do:

Increase team's proficiency by ensuring adequate training, coaching and development of technicians in function of the team and people potentials
Ensure required corrective actions are taken and put in force
Implement and communicate on important metrics with its related corrective actions
Be prepared and participate actively to weekly/monthly planning meetings, propose solutions, demonstrate proactivity to ensure adherence to plan and performance
Ensure that the infrastructure including facilities, utilities and equipment are well maintained
Be accountable for a proactive collaboration with different partners
Ensure followup and compliance of procedures and instructions, and update if needed, as well as corrective actions and preventive actions
Ensure audit readiness, participate to the preparation, and the realization of audits
Ensure adequate training/mentor of technicians/samplers linked to the activities requested and performed

Education and skills:

Master or a graduate degree with demonstrated experience in environmental monitoring in a pharmaceutical area.
3 years or more in industry related to aseptic activities
Knowledge on the use of LIMS software for sample management, and Trackwise for deviation management, change control implementation, CAPA, etc are assets
Speak and write on a professional level in French and English