Quality System Management

2 weeks ago

London, United Kingdom BioTalent Full time

Title: QSM Contractor

Location: London, UK

Day Rate: Competitive

Employment Type: Contract

BioTalent is delighted to be partnered with a leading Biotechnology Research company based in the UK and we are on the hunt for a brand-new QSM Contractor to join the team on a hybrid, contract basis.

The Role:

  • Support the maintenance of the Quality Management System, act as Business Administrator for Veeva eQMS, oversee quality associated records and ensure these activities conform to regulatory requirements.
  • Manage the controlled document scheme, act as GxP archivist, and deliver QA training activities. duties within Quality function.
  • It is desirable, but not essential for the candidate to have a comprehension of basic Veeva configuration to assist them with troubleshooting issues that my arise and to complete basic configuration changes such as workflow adjustments and additions and removals to configured lists

Profile Required Essential:

  • Act as Business Administrator for Veeva QualityDocs, Veeva eQMS and Veeva training.
  • Act as the core subject matter expert for the company document management system, be the primary point of contact for document management queries and represent the system during regulatory and client audits/ inspections.
  • Management of the training matrix and Veeva Training to ensure fit for purpose.
  • Provide support and QMS data for internal and external meetings, including the Quality/Metrics Strategic Working Group (SWG). Maintain reports and dashboards in Veeva.
  • Provide eQMS training to ensure competence across the business and maintain associated controlled documents.
  • Ensure the appropriate storage of GxP documentation. Act as the primary company archivist by coordinating and preparing documentation for the offsite archive. Ensure appropriate process in place for the recall of documents when requested.
  • Administration of the quality assurance logs such as signature, notifications, QTA and audits.
  • Document owner for GxP documents such as policies and the quality manual.
  • Manage the controlled document scheme, including issuance and reconciliation.
  • Provide information for Batch Record Review, QP certifications, Sponsor Release as and when requested

If you are keen to find out more about this Quality System Management role, please reach out.

BioTalent Ltd are acting as an employment agency in relation to this opportunity.

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