Quality Documents and Training Administrator - III

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United Kingdom
Uxbridge, England
Posting date: 25 Oct 2019
QA.RH.25939_1572026161

A vacancy has arisen for an Quality Documents and Training Adminstrator - 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:

  • Support the Global Document Management and Training Administration programs:
  • Administrate the electronic Document Management System (eDMS) and Learning Management System (LMS) including managing user accounts, assigning access rights and initiating workflows.
  • Administrate Procedural Documents and Quality records through the eDMS, including the change management, electronic review/approval, periodic review and obsoletion workflows.
  • Enter data into the eDMS and LMS.
  • Perform 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.
  • Serve as functional liaison with local Procedural Document and training coordinators at International affiliate locations.
  • Address and resolve customer questions promptly and maintain close cooperation and communication with international affiliate personnel.
  • Deliver system/process training to general users.
  • Provide ongoing user support on system(s) and department processes.
  • Ensure consistent application of systems and process.
  • Support the creation and implementation of globally standardized processes applicable to the quality management system and their deployment to headquarter and affiliate locations.
  • Provide support in regulatory agency inspections; may coordinate audit follow-up and corrective action planning with appropriate functional areas.
  • Track and monitor department workloads ensuring business priorities are addressed.
  • Maintains process metrics.
  • Contributeto continuous improvement initiatives.
  • Lead 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 Masters degree) in a relevant field, such as a Quality Control, Quality Assurance, Regulatory Operations or similar GxP/Regulated environments.
  • Experience with eDMS eg Veeva Vault, MasterControl, Documentum is highly desirable
  • Must have experience managing content in an eDMS or LMS.
  • 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 Ronni Hartgen at +44 2038000814 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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