When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
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.
How will you make an impact?
Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by FDA, EMEA, ICH etc. To achieve compliance, quality systems are defined, implemented and maintained. The Quality Systems Group is responsible for developing, implementing, updating and auditing the documented Quality System of Thermo Fisher Scientific Groningen, and for keeping the regulatory status of the Thermo Fisher Scientific Groningen site updated.
What will you do?
Ensure timely update of all procedures
Assure compliance with all relevant international regulations and guidelines
Support all compliance activity on site includit audits and inspections
Ensure full coverage of the operation by adequate Quality System
Support implementation of improved documentation practices and documentation control systems
Support continuous improvement of Quality systems including Documentation;
Maintenance of the Quality Management System;
Status promotion in the documentation system (effective, retired)
Issuing controlled documents (e.g. Protocols)
Generation of accurate copies of Controlled Documents (on paper or electronic)
Tasks related to document management and quality administration as indicated by management
Monthly report performance of QA PIs
Monthly report performance of Thermo Fisher Scientific Quality System
Support of and participation in audit process.
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;
Alignment of Standard Operating Procedures, documentation practices, laboratory testing, and efficient documentation flows in the Quality release of raw materials, buffers/media and area/equipment;
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;
Application of cGMP change control;
Work with complex and comprehensive electronic databases (e.g. Trackwise) to document events related to product quality;
Support regulatory inspections from readiness exercises through direct agency engagements;
Operate in a variety of modes as it pertains to risk adjusted Quality oversight models driven by the mode of manufacturing being employed;
Effectively communicate in multiple modalities (e.g. electronic, written, verbal, etc.);
Execution of internal audits.
How will you get here?
Bachelor level in a relevant discipline (Biochemistry, Microbiology, Biotechnology, pharmacology) or equivalent
Minimum of 5 years relevant experience in a (bio) pharmaceutical company;
Experience with project management.
Knowledge, Skills, Abilities
Excellent knowledge of pharmaceutical cGMP systems and international cGMP regulations and guidelines;
Planning & organization.
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.