Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Location/Division Specific Information
The Groningen site is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (phase 1, 2 and 3) and commercial production. Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by FDA, EMA, ICH, etc
How will you make an impact?
To assure compliance, quality systems are defined, implemented and maintained. The Quality Affairs Department is responsible for development, implementation, updating, auditing of and reporting on the status of the Quality Systems of Thermo Fisher Scientific Groningen and operational Quality Assurance, Quality Control tasks in relation to the manufacturing operations and batch disposition decisions.
In a team of 10 colleagues, the Quality Assurance Officer serves to ensure that cGMP manufacturing activities are completed in accordance with cGMP requirements (e.g. good documentation practices), adhere to the approved Standard Operating Procedures, are consistent with emerging/existing corporate & regulatory guidelines as necessary and are continuously improved through leveraging the Quality Systems architecture and execution by the organization.
What will you do?
Quality on the floor: direct engagement, real time, of Quality professionals with manufacturing shop floor operations including cGMP guidance, document review and approval, deviation handling and advice regarding documentation quality practices. Shift work is required.
Practical application of various risk assessment tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies) and the ability to directly develop, participate and advise others on the appropriate and efficient application of these processes.
Use, scope, development and orchestration of incident investigations toward the goals of both adequately understanding root cause (including causality vs correlation) and avoiding repeated incidence (corrective action, preventative action and effectiveness verification). Handling of deviations.
What do you have?
Minimal bachelor (HBO) level in a relevant discipline (Biochemistry, Microbiology, Biotechnology, pharmacology) or equivalent.
Preferably 1 year of relevant experience in a (bio) pharmaceutical company.
Good knowledge and working in cGMP environment.
Good knowledge of pharmaceutical cGMP systems and international cGMP regulations and guidelines
You are cooperative, disciplined, driven and reliable.
Demonstrated commitment to our fundamental principles of Integrity, Respect and Excellence
Accomplished in planning and organizing.
You have good understanding of English in word and writing.