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?
The Quality Assurance on the floor officer serve 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. Significant shift work may be 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;
- Understanding of the connection between floor documentation and the batch disposition process;
- Advise, facilitate, and support all phases of manufacturing batch documentation development including, but not limited to the initiation, authoring, approval and mastering;
- Quality review and approval of cGMP documentation;
- 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?
- HBO (bsc.) level in a relevant discipline (Biochemistry, Microbiology, Biotechnology, Pharmacology ) or equivalent.
- Minimum of three years relevant experience in a (bio) pharmaceutical company;
- Experience with project management.
Knowledge, Skills, Abilities
- Knowledge of pharmaceutical cGMP systems and international cGMP regulations and guidelines.
- Problem analysis;
- Result oriented;
- 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.