Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
The Qualified Person (QP) is an important role in maintaining the high quality standards at the Tilburg site. The QP supports changes, problem investigations, identification of solutions and releases products produced at the Tilburg site. The QP communicates both within the site as well as direct with customers.
This is a high-level independent, Quality oriented role that reports directly to the Site Quality Head. This role also includes responsibilities as core team member that is actively involved in multifunctional project teams that support the growth of Thermo Fisher’s internal product pipeline, external client-based product development, and technical support for on-site operations. This is an excellent opportunity for Quality professionals with experience developing quality systems within a GMP/GLP environment.
The QP plays a relevant role in the production of product within existing regulations and company Quality standards. You will help others, from all available teams at the site, in their grow of understanding pharmaceutical requirements. You will independently release product and agree with customers on problem and solution. Also you will host regulatory and customer audits. The QP stimulates continuous Quality improvements on the site.
What will you do?
Represent the site from a Quality perspective. As core team member in projects you will assure adherence to regulatory guidelines and company Quality policies. In addition, you will support investigations and suggest solutions.
Work closely and collaborate with all entities within the site organization.
Assess product produced site for compliance with GMP regulations and company Quality standards. Release product when compliance is evidenced.
Find the best scientific strategy to characterize the quality, safety, and efficacy of our products.
Telling the story to drive decision-making: present scenarios and recommendations by ensuring that all activities are focused on answering questions that lead to better decisions and high-quality products for our internal and external customers.
Liaises with internal Quality functional areas to meet project and team objectives.
Perform all duties in compliance with Quality standards, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.
Collaborate with peers.
How will you get here?
A master’s degree in pharmacy. Alternatively a master’s degree in chemistry, biochemistry or related physical science combined with completed additional QP course valid for recognition by the Dutch authorities.
Preferably experience (2+ years) in working in the pharmaceutical industry, preferably in a quality role. Equivalent combinations of education, training, and relevant work experience may be considered.
A passion for development strategies and solving problems.
Confirmed knowledge of subject matter(s) related pharmaceutical regulations, along with a sound understanding of principles and concepts in other relevant subject areas.
Able to shepherd projects with medium to high complexity to completion by getting help from others as an individual leader and contributor.
Ability to effectively set goals, priorities and time required. Can indicate courses of action, required resources, bring up potential issues, and make adjustments as needed to achieve particular goals.
A person who enjoys working in a team, embraces the challenges that are related to regulated production, discovers happiness in this role.
Diversity is an important element for our teams to build an effective and challenging working environment. Integrity, Intensity, Innovation and Involvement are key characteristics that we expect of all members of our community.
Anyone that is already challenged by this position or first would like to know more about it is highly encouraged to respond to this vacancy. This will enable us and you to find out whether you might be the colleague that we are looking for and providing you the opportunity to grow and develop yourself with your contribution in our mission to serve our customers.
We offer
Excellent career opportunities within a large and growing global employer.
Competitive salary.
Annual Incentive Plan (bonus).
Generous benefits package.