Qms Business Administrator - Zwijnaarde, België - Meet Recruitment
Beschrijving
Competitive- Zwijnaarde, Belgium, Belgium
- Permanent
QMS Business Administrator
My client is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. They are looking to hire an experienced Quality Systems Business Administration Associate to expand their Quality Team.
This is a brilliant opportunity to join a fast growing biotech company and become a part of an amazing Computer Systems Quality team as a key business partner working with the Business Information Systems Group and Business and Application owners.
Skills and Experience
- Minimum of 3 years' experience with business administration of quality systems and follow up monitoring
- BS in technical disciplines involving engineering or quality (i.e., Computer Science)
- Experience working in business administration of quality systems in pharma setting.
- Understanding of FDA, PMDA, EU regulations and ICH Guidelines.
- Strong technical mastery in quality systems, analytical and investigation skills.
- Proven ability to collaborate effectively with stakeholders from different Functional Areas as a strong team player.
- Able to work effectively together with both internal and external stakeholders
Roles and Responsibilities
- Support setup and configuration for electronic quality system
- Support implementation and maintenance of future ready quality systems.
- Manage direct daytoday GxP quality system
- Performing routine activities maintaining picklist & objects, include foundation information, templates and user requests
- Support global continuous improvement initiatives of Computer Quality Systems
- Provide monitoring and management of the systems (eg. via reports/dashboards)
- Support in new releases, quality systems and business activity as business admin
- Provide support to global quality organization through ad hoc quality tasks
What is in it for you?
- A competitive salary package
- Extensive benefits
- Front seat in the development of therapeutic antibodies
- A work environment in a humansized, dynamic and rapidly growing biotech company
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