Overview
Quality Specialist II Jobs in Allschwil, Kanton Basel-Landschaft, Switzerland at ThermoFisher
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.
Deviation Writer
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.
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 resolve appropriate preventative and corrective actions.
Trend,analyseproduct-complaintinvestigation data,and address appropriately aswellasliaisonwith production and quality.
Work independently to follow guidelines relating to deviation and complaint investigations.
Close relationship with 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.
Experienceina
GMPfacility.
Very good 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.
Abilitytowriteconcisely,expositoryanddescriptive.
Job Summary
Job number: R-Date posted :
Profession:
Quality & Regulatory
Employment type:
Full time
Title: Quality Specialist II
Company: ThermoFisher
Location: Allschwil, Kanton Basel-Landschaft, Switzerland
Category: Healthcare, Quality Assurance – QA/QC
