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Quality Services Document Control Associate

QA Document Control Pharmaceuticals

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Astellas Pharma Europe B.V. we are searching for a Quality Services Document Control Associate.

Keywords
  • BSc.
  • Pharma industry
  • QA / documentation
  • Electronic Document Management System

As Quality Services 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 QA mission, objectives, and 3-5-year strategic plan. You will functions as the QA point of contact for all functional areas utilizing the Astellas EDMS and you supports the QA staff of approximately 170 individuals in addition to global end-users, by offering consultation, advice, and subject matter expertise regarding QMS document control requirements and business process.
Responsibilities:
  • 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 Electronic Document Management System (EDMS) workflows;
  • Ensure impacted stakeholders are involved in the review of new and revised Quality Documents;
  • Support the development, review, and delivery of training materials to provide to new users of the EDMS system;
  • Provide guidance on proper methods for writing SOPs and other Quality Documents to meet standards;
  • Support Document Management / Document Control initiatives that lead to process improvements;
  • Support EDMS end-users on document retrieval for superseded and obsolete documents as well as completing requests for uploading documents and related translations into the EDMS.

Profile

We are looking for you in you have at least a Bachelors degree in Science en some years (2 - 5) of experience in the pharmaceutical industry within QA and/or Document Management.
You have:
  • Strong interpersonal skills and multicultural /intercultural awareness, able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration;
  • Ability to work independently, multitask and shift workload according to department/team priorities;
  • Strong planning and organizational skills and experience managing and delivering on multiple priorities in a timely manner.
  • Ability to demonstrate critical thinking while analyzing / resolving issues and improving processes.
  • Proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint) and PDF editor software (e.g., Adobe Professional, Foxit).
  • High attention to detail.

Experience with an EDMS system like Veeva Vault Quality or Master Control is preferrend. Are you the enthusiastic candidate with excellent communication skills we are looking for?

Benefits

Contract for at least 12 months.
Remote work is possible.
Salary: max 41000
Days of leave: 38
See here our other employment terms for this vacancy

Company profile

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.

Contact

Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.
Location Leiden
Quality Services Document Control Associate

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