Pharmaceutical Document Control

Wat ga je doen?

OBJECTIVES
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. Contributes to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 year strategic plan.

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 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  • Support ADMS QD users on document retrieval for superseded and obsolete documents as well as completing requests for uploading documents into the ADMS QD Repository.

Waar ga je werken?

Astellas is a Japanese multinational pharmaceutical company employing over 18,000 people worldwide with global sales exceeding 10 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.

In this position, you report to the Associate Director, Quality Systems Document Control and Administration and collaborate directly with CRQA Leadership Team, CRQA staff, and various levels within Medical and Development (M&D) functions including functions outside of M&D that utilize ADMS QD. The office is located in Leiden.

Wie ben je?

Required skills

  • Bachelor of Arts/ Bachelor of Science degree BS/BA.
  • 2 - 5 years working experience in the pharmaceutical industry, one of which should be within Quality Assurance and/or within SOP writing, Process Improvement or similar discipline.
  • Proficiency in Microsoft Office.
Skills and Competencies

  • Strong interpersonal skills and multi-cultural /intercultural awareness, able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration. Excellent oral and written communication.
  • Ability to work independently, multitask and shift workload according to department/team priorities. Strong planning and organizational skills and experience managing multiple priorities simultaneously.
  • Working knowledge of Microsoft Office tools (e.g., Word, Excel, PowerPoint) and PDF editor software (e.g., Adobe Professional, Foxit).
  • High attention to detail.
Prefered Skills

  • Experience processing documents for review and approval using an electronic system.

Wat mag je verwachten?

  • A diverse job within a pharmaceutical company
  • A temporary, fulltime contract for one year
  • Salary based on experiene (range: €2700 - €3800)


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