Team Leader, QC Micro

at  Thermo Fisher Scientific

JOB DESCRIPTION

When you’re part of the team at Thermo Fisher Scientific, you’ll do important and strategic work: you will help customers in finding cures for cancer and several diseases, also rare pathologies, working on new and innovative molecules for strategic therapies and most as promising and innovative drugs for treatments for all patients, including children always pointing our attention to save lives and giving to many people big hope for a healthier future.
Your work will have real-world impact, and you’ll be supported in achieving your career goals!

KNOWLEDGE, SKILLS, ABILITIES

• Coaching Leadership style with ability to set clear direction and delegate authority.
• Being a role model leader in developing and motivating people at all levels
• Strong team player and leader with the ability to work across multiple functions and subject areas.
• Creating an energetic and forward-looking environment.
• Build trustful and strong networking relationships.
• Knowledge of the main techniques of microbiological (Bioburden, Sterility and Endotoxins and environmental monitoring).
• Knowledge of GMP and national/international regulations (e.g. Annex 1).
• Knowledge of Sterile injectable drugs production processes.
• People management skills.
• Fluent English
• Proficiency in Microsoft Office suite
• Be prepared to work with conflicting priorities, under time constraints and in a dynamic team environment.
  This role requires a wide degree of flexibility, multitasking and open-minded demeanor with ability to prioritize multiple tasks and, problem solving demeanor and decision making along with influencing capacity, customer and result-orientation.

• Draw up study protocols and reports for environmental monitoring.
• Lead and handle external inspections, e.g. from Competent Authorities, Notified Bodies, customers and other third-party Quality System evaluations.
• Participates in calls/meetings with customers to support the discussion on technical topics for their area of expertise.
• Collaborates in handling laboratory investigations (Out of Specification, CAPA and Deviation Reports).
• Be in charge of analytical activities and environmental monitoring scheduling.
• Be the ambassador for continuous improvements of product quality and services.
• Maintain up-to-date knowledge of all applicable regulations, guidelines, and standards.
• Have the role as Management Representative for microbiological laboratory