Quality Specialist II
Vor 2 Tagen
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
When you’re part of Thermo Fisher Scientific, you’ll do daring work, and join a team that values performance, quality, and innovation. A successful, growing global organization. You will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.
Job Summary: The Deviation Writer will 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, collect information from all relevant 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.
- Lead and support investigations across Packaging, Clinical Labelling Services, Distribution and other departments to ensure timely closure for each investigation and follow-up activities.
- Work with the functional areas to identify the most probable root cause(s) and resolve appropriate preventative and corrective actions.
- Trend, analyse product-complaint investigation data, and address appropriately as well as liaise with production and quality.
- Work independently to follow guidelines relating to deviation and complaint investigations.
- Maintain a close relationship with the packaging/distribution floor.
Qualifications:
- Degree in the field of Biology, Microbiology, Chemistry, Pharmacy or similar.
- Minimum 2 years of experience in deviation and investigative writing experience desirable.
- Experience in a GMP facility.
- Very good speaking and writing skills in German and English.
- Strong critical thinking and deductive reasoning skills.
- Excellent interpersonal and communication (written and verbal) skills.
- Strong MS Office skills.
- Ability to write concisely, expository and descriptively.
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