Quality Documents and Training Administrator - III

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United Kingdom
Cambridge, England
Posting date: 16 Oct 2019
QA.SF.25830_1571242831

A vacancy has arisen for a Quality Documents and Training Administrator - III with an internationally renowned pharmaceutical company, based in their UK office. This organisation is known for its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. This is an exciting opportunity to work with a leading pharmaceutical organization and support their innovative impact on the healthcare field.

Job Responsibilities:

  • Administrates the electronic Document Management System (eDMS) and Learning Management System (LMS) including managing user accounts, assigning access rights, and initiating workflows.
  • Administrates Procedural Documents and Quality records through the eDMS, including the change management, electronic review/approval, periodic review, and obsoletion workflows.
  • Enters data into the eDMS and LMS.
  • Performs quality control of entered data and follows appropriate procedures to ensure the quality of information contained in the eDMS and LMS with global quality standards.
  • Serves as functional liaison with local Procedural Document and training coordinators at International affiliate locations.
  • Addresses and resolves customer questions promptly, maintains close cooperation, and communication with international affiliate personnel.
  • May deliver system/process training to general users.
  • Provides ongoing user support on system(s) and department processes.
  • Ensures consistent application of systems and process to ensure the quality of their work, and the high standards expected in Compliance.
  • Must be able to use systems to organize and check information, ensuring a high level of accuracy, quality, and consistency.
  • Supports the creation and implementation of globally standardized processes applicable to the quality management system and their deployment to headquarter and affiliate locations.
  • Provides support in regulatory agency inspections.
  • Tracks and monitors department workloads ensuring business priorities are addressed.
  • Maintains process metrics.
  • Contributes to continuous improvement initiatives.
  • Leads relationships with specific departments as a business partner.

Skills and Requirements:

  • 4+ years of relevant experience with a BS or BA degree (or 3+ years with a Master's degree) in a relevant field, such as a Quality Control, Quality Assurance, Regulatory Operations, or similar GxP/Regulated environments.
  • Experience with eDMS, e.g. Veeva Vault, MasterControl, and Documentum is highly desirable.
  • Must have experience managing content in an eDMS or LMS.
  • Must work well on a virtual team and with capability to work independently where needed.
  • Must have demonstrated ability and willingness to conduct routine work, such as data entry to a high standard of accuracy, while displaying flexibility and independence in spotting or anticipating/resolving problems.
  • Experience corresponding with people who use English as a second language is an advantage.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Steven Fuller at +44 203 854 2630 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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