Quality Systems Document Control
Astellas Pharma Europe B.V. - Leiden (Nederland)
For our client, Astellas Pharma Europe B.V., we are looking for a Quality Systems Document Control.
In your role as Quality Systems Document Control Associate you are responsible for the development and maintenance of the Quality Management System (QMS) Document Control system supporting Regulatory Affairs, Pharmacovigilance, Development, Medical Affairs, and other functions that utilize the Medical and Development QMS. You will contribute to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 year strategic plan.
- Function as the Quality Document (QD) Administrator responsible for reviewing new or revised Quality Documents for compliance to established standards;
- Ensure all Quality Documents meet required standards before processing documents in the Astellas Document Management System - Quality Document (ADMS QD) workflows;
- Ensure impacted stakeholders are involved in the review of new and revised Quality Documents;
- Deliver effective communication of requirements and standards to Authors of Quality Documents as well as to the Users of the Astellas Document Management System - Quality Document (ADMS QD);
- Support the development, review and delivery of training materials to provide to new users of the ADMS QD system;
- Provide guidance on proper methods for writing SOPs and other Quality Documents to meet standards;
- Support Document Control initiatives that lead to process improvements;
- Respond to email inquiries and user support questions;
- Support ADMS QD users on document retrieval for superseded and obsolete documents as well as completing requests for uploading documents into the ADMS QD Repository.
Who we're looking for
We are looking for an enthusiastic candidate with a Bachelor degree with some experience in the pharmaceutical industry. Preferable, you have experience within Quality Assurance and/or within SOP writing, Process Improvement or a similar discipline. You are competent in the use of an electronic document management system (EDMS) such as Documentum or Veeva Vault Quality. You are proficient in working with Microsoft Microsoft Office tools (e.g., Word, Excel, PowerPoint) and PDF editor software (e.g., Adobe Professional, Foxit).
Because of the intercontinetal team, it is important that you are a self-starter and that you can work independently. Excellent communication skills are a must. You can multitask and shift workload according to the department/team priorities and you have strong planning and organizational skills.
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Salary: 35000|
Days of leave: 25 + 13
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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