Scrum Master SF-10 ILLSDC wet/IBP&S ART

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 analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our organization of more than 120,000 colleagues delivers an outstanding 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.

Our site in Groningen is part of the world-class Pharma Services of Thermo Fisher Scientific. We operate in a sophisticated and highly regulated environment. You’ll do important work, like helping customers in finding cures for cancer! You will have a real-world impact. Pharma Services offers our clients a powerful platform for their drug development with technologies that are industry standard to state-of-the-art (including Single Use Technologies such as Single Use Bioreactors).

The Groningen site is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for both clinical trials (phase I, II and III) and commercial applications. This type of facility has to follow rules and regulations of cGMP set by countries health and welfare ministries and with internationally harmonized guidelines that give guidance with implementing these rules and regulations.

The production activities have to be performed in an efficient and effective manner to assure the sites overall competitiveness. In addition, due to the very high value of intermediates and products, production activities are preformed in a highly controlled fashion (Cleanroom environment).

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.

The Quality Officer on the floor 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 demonstrating the Quality Systems architecture and execution by the organization.

The job of Quality Officer on the floor will include a selection of the responsibilities mentioned below:

• 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.

• 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.

• HBO level in a relevant field (Biochemistry, Microbiology, Biotechnology, pharmacology) or equivalent.

• Proficient in English

• Minimum of 5 years relevant experience in a (bio) pharmaceutical company.

• Excellent knowledge of pharmaceutical cGMP systems and international cGMP regulations and guidelines.

• Experience with project management.

• Good interpersonal skills.

• Flexibility

• Communication

• Problem analysis

• Initiative

• Judgement

• Independent

• Result oriented.

• Persuasiveness

• Planning & organization

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.