Job Detail

Job Description

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.

Fisher Clinical Services GmbH is part of Thermo Fisher Scientific Corporation, a world-class company serving the scientific community and healthcare industry. We are leaders in providing clinical supply chain management services and clinical supplies distributed to patients worldwide. For more information about our site in Allschwil please visit: www.fisherclinicalservices.com

Deviation Writer Operations

Job Summary:

Conduct and write formal investigation of process deviations for Packaging Operations with the assistance of site personnel. This position will also perform initial and final impact risk assessment as well as assist in root cause determination and plan appropriate corrective action and preventative action. The incumbent will also assist in the tracking and trending of historical data and assure timely closure.

Responsibilities:

• Ensure compliance with relevant SOP’s while gathering, analysing and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation and complaint has on the product, process and patient health and safety.


• As part of each investigation, gather information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously packed product, as well as the risk to future operations.


• Leads and support investigations across Packaging, Clinical Labelling Services, Distribution and other departments to ensure timely closure for each investigation and follow-up activities.


• Works with the functional areas to identify the most probable root cause(s) and determine appropriate preventative and corrective actions.


• Trend, analyse product-complaint investigation data, and address appropriately as well as liaison with production and quality.


• Work independently to comply with procedure driven guidelines relating to deviation and complaint investigations.


• Observing the packaging/distribution floor in order to gather pertinent information of the process.

Qualifications:

• Degree in the field of Biology, Microbiology, Chemistry, Pharmacy or similar


• Minimum 2 years of experience in deviation and investigative writering experience desirable.


• Experience in a GMP facility.


• Advanced speaking and writing skills German and English.


• Strong critical thinking and deductive reasoning skills.


• Excellent interpersonal and communication (written and verbal) skills


• Strong MS Office skills.


• Must be able to write concisely, expository and descriptive.

At Thermo Fisher Scientific, each one of our 70,000 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 jobs.thermofisher.com