About this role

  • Location

    Cambridge, Cambridgeshire

  • Salary

    £400 - £450 per day

  • Type

    Contract

  • Division

    quality-assurance-jobs

  • Reference

    8781_1570021571

  • Start date

    ASAP

  • Managing this role

Executive Consultant

Leanne Delaney

0203 865 5838

Leanne@xplorepharma.com

Description

I’m partnered with a Large Pharmaceutical organisation based in Cambridge. They are looking for a Quality Documents and Training Administrator with the following skills to join their team for a 12 Month Contract.

Quality Documents and Training Administration support the organisation’s enterprise wide compliance with ICH GCP, GPvP and associated regulations through provision of high-quality support and service in administering and maintaining the Global Quality Management System.

Key responsibilities:

  • Support the Global Document Management and Training Administration programs:
  • 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
  • Ensures consistent application of systems and process to ensure the quality of their work, and the high standards expected in Compliance
  • 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. May coordinate audit follow-up and corrective action planning with appropriate functional areas

Experience

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 eg Veeva Vault, MasterControl, Documentum is highly desirable

Essential Skills

  • Must have experience managing content in an eDMS or LMS
  • Must be proficient with Microsoft Word and Excel (advanced skills preferred)
  • Must possess exceptional organizational and time management skills with ability to work on specified projects to tight timelines
  • Work well on a virtual team and with capability to work independently where needed
  • 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
  • Excellent computer skills in standard office programs and must be able to learn new computer systems quickly.

Offering: 12 Month Contract working in Cambridge

If this role sounds interesting, please get in touch via email or phone. Send your CV to Leanne@xplorepharma.com

This role is urgent, and with the high volume of applicants we may not be able to get in touch with everyone. Interviews will happen as and when a great candidate gets in touch.

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