Technical Specialist QC in Microbiology Leiden • TMC

Wij zijn een internationaal hightech consultancybureau met een team van ondernemende ingenieurs, wetenschappers en digitale experts van over de hele wereld. We bieden consultancydiensten aan onze toonaangevende klanten in diverse servicegebieden zoals:

• Technology & Engineering
• Energy & Renewables
• Life sciences & Pharma
• Digital & IT

The Technical Specialist will actively handle the Medium and High quality and compliance issues at the lab independently or with help of the lab technicians. Will work to maintain cGMP compliance and LEAN status of the team. Act as Subject Matter Authority during cGMP inspections and is SPOC (Single point of contact) for the lab during new product implementations, investigations, qualifications, etc. 

The key responsibilities of the jobholder:

• Responsible for deviation management, acting as lead investigator for non-conformances and coordinator of appropriate corrective/preventive actions.
• Creates, reviews and updates lab documentation and supporting documents for New Product Introductions.
• Provides technical support to the lab, input in services group and cooperates with local/global customers.
• Acts as a technical system owner for (analytical) equipment.
• Acting as Subject Matter Authority during audits and inspections.
• Leads and drives continuous improvement projects.
• Role model to safety, compliance, and reliability
• Responsible to communicate and interact effectively with team members; develop credibility and trusted mutually respected relationships with customers, supervisors, and team members.

We would love to hear from YOU, if you have the following requirements: 

• Bachelor’s degree (HLO) or higher education in Life Sciences, molecular biology or comparable
• Written and oral communication skills in English.
• Ability to work independently as well as collaborate with cross-functional teams to accept challenges and responsibilities
• Proven experience with microbiological techniques, such as bioburden, endotoxin, and sterility is preferred.
• Analytical thinking and (technical) problem solving.
• GMP experience is a plus

TMC is an international high-tech consultancy company that brings expertise to their clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster changing technological world. Our business cell lives by 3 principles:

• Best over biggest.
• Collaboration over individualism.
• Values and ethics over rules.

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