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Seagen
QA Associate II
Global Quality - Zug, Switzerland
Description
Position Summary:
This role is to support multiple activities within global Quality operations including process improvement initiatives in ESO QA and Country QA, and inspection support, etc. . This role includes the responsibility to collect data and summarize the data for the KPI program for the above organizations. Additionally this role is responsible for supporting the owner of the capacity modelling tool for Global Quality Operations (External & Internal).
Principal Responsibilities
- Write and review Standard Operating Procedures as needed
- Support regulatory inspections of Country affiliates.
- Support ESO & country QA in follow up of CAPA
- Support Process Improvements projects
- Support Implementation of risk management in ESO
- Support maintaining the risk register of CMOs
- KPI program management for Global Quality Operations and reporting
- Responsible for Training coordination for Global Quality Ops teams
- Administration of routine processes (upload and management of records, lot file preparation, record archival, etc.)
- Facilitate inspection readiness meetings with agenda and action item follow ups
- Responsible for establishing and maintaining tools for executing work (systems)
- Support new system implementation; may participate in testing functionality to support Quality operations processes
- Be a super user for some of the electronic systems e.g. Viva, Oracle etc.
Qualifications
- 1-2 years experience in working in a GMP environment
- Good Understanding of pharmaceutical development & manufacturing
- Good knowledge of IT tools like Excel, Powerpoint, Word, Adobe etc.
- Excellent verbal and technical written communication skills,
- Good interpersonal skills, and negotiation skills
- Innovative, proactive, and resourceful; committed to Quality and continuous improvement
Education:
BS/BA or Masters Degree in a relevant field like Pharmacy, Chemistry or any other life science subjects.
As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit www.seagen.com
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 01/22/2021
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