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.
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.
The Quality Assurance officer serve to ensure that all validation activities on site 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.
Direct engagement, real time, with Engineering / validation department and manufacturing shop floor operations including, validation strategy, cGMP guidance, document review and approval, deviation handling and advice regarding documentation quality practices.
Calibration and maintenance support in equipment and system lifecycle
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.
To work collaboratively and also across functions to successfully implement and maintain the site Validation programme.
Quality review and approval of validation documentation (IQ, OQ, PQ, SAT etc)
Equipment and system purchase support, URS review, evaluation of validation packages etc.
Alignment of Standard Operating Procedures, documentation practices, laboratory testing, and efficient documentation to support Engineering department.
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
Proven experience in a Validation role and/or Technical role in combination with relevant quality experience in a Biotech/ Biopharma/ cGMP environment..
Experience with project management.
Excellent knowledge of installation, instrument and equipment validation, pharmaceutical cGMP systems and international cGMP regulations and guidelines.
Bsc. or Msc. level in a relevant discipline (Biotechnology, engineering) or equivalent.