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 complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled 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.
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. Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by FDA, EMA, ICH etc. To achieve compliance, quality systems are defined, implemented and maintained.
How will you make an impact?
The Thermo Fisher Scientific site in Groningen manufactures many new biopharmaceutical products for several stages of clinical trials and commercial manufacturing. The extend of the application of the cGMP system and the degree of testing varies with the stage of the product. The QC Support Officer will support the QC team in the broadest sense, to assure timely output of the Quality Control department, according the international regulatory requirements and is responsible for accurate and timely support at a good level to the QC technicians, QC scientists and other internal contacts. Communication throughout the internal and global organization and with customers.
What will you do?
The Groningen site is a multiproduct and multi-client site that provides full spectrum biopharmaceutical manufacturing services (i.e. development, clinical trials, process performance qualification and commercial manufacturing) in the production of bulk Active Pharmaceutical Ingredient (API)/Bulk Drug Substance (BDS) via mammalian cell culture. This facility complies with all rules and regulations of current Good Manufacturing Practice (cGMP) set by individual jurisdiction health and welfare ministries while leveraging international and industrial standard guidelines to speed the efficient and flexible conversion of development insights into the reality of bulk biopharmaceutical manufacturing. Proactive and thorough compliance with the legally enforceable rules and regulations while leveraging the applicable guidelines is an essential part of the strategy of this site to provide patients with safe therapeutics while providing clients with reliable, quality, and cost competitive product that enables successful commercialization.
Scientific: The job holder needs to have elementary knowledge of assays in general. The job holder needs to have extensive knowledge of Quality Control and related regulatory requirements.
Organization: The job holder works in a multidisciplinary team (internal and external (= contract lab ). The job holder has customer and external focus and contacts. The job holder needs excellent communication and interpersonal skills to achieve the overall team/customer result. A pro-active attitude and personal initiative is expected to identify and overcome practical problems.
Networking: The job holder is operating in a wide network within and outside Thermo Fisher Scientific.
Key Areas of accountability/responsibility
The QC officer is responsible for specific tasks assigned, like external testing, stability, shipments of samples or reference standards
Contributes to the preparation of Certificates of Analysis, both for internal and external testing, in accordance with the release schedule, and assure accuracy of the output;
Responsible for alignment of local requirements versus global requirements, e.g. GAP analysis and corrective actions;
Actively initiates/participates in improvement projects in close collaboration with QC (support) manager;
Initiate and investigate deviations and change requests to support the Quality Control.
Contributes to the effectiveness of the Quality Control department, in order to safeguard the output, whilst operating within EH&S guidelines and Quality standards;
Active backup of colleague QC support officer during absence and vacations, and upon request;
What do you have?
Bachelor’s degree (HBO) or higher, discipline (Biochemistry, Microbiology, Biotechnology, Pharmacology) or through relevant experience laboratory education and experience in the Quality Control area;
Sound knowledge on Quality Control in the pharmaceutical industry.
At least 3 years of relevant experience in a (bio)pharmaceutical company, with proven seniority;