Research Quality Association

QA Coordinator

Phlexglobal Limited
Amersham, Buckinghamshire, South East England, United Kingdom
30 days ago

Description

Phlexglobal is the leading technology and services organisation for clinical and regulatory matters with a focus on helping clients to master their digital agenda via proven AI solutions. Phlexglobal combines software and leading expert services to offer a unique solutions portfolio with easy to achieve automation via data generation that lifts organisations to a new level of effectiveness.

The QA Coordinator will support aspects of the quality agenda ensuring a professional Quality Assurance service is delivered. You will do this by supporting the effective execution of QA policies and processes in accordance with applicable regulations and company quality standards. This role will also be involved in supporting customer audits, conducting internal audits and general quality assurance tasks.


Key Activities:

  • Support the development, management and improvement of quality management systems and procedures to ensure compliance
  • Assist with the maintenance and timely revision of SOPs, Quality Management System and Quality Manual including controlled documentation registration, version control, history of SOPs.
  • Respond to requests for approval forms and editable versions of documents.
  • Ensure QA systems are always updated and accurate.
  • Maintain document repository in the Quality Management System.
  • Maintain & review quality related documentation.
  • Perform internal audits in accordance with the internal audit schedule.
  • Provide support in the preparation and coordination of inspections/audits by regulatory authorities and clients. Support and facilitate client audits and follow up responses including, but not limited to, arranging audit logistics, preparation of documentation and overseeing responses to audits.
  • Interact with clients, as required, during audit preparation. May host some customer audits independently as directed by QA management. Assist in preparation and review of corrective actions plans associated with customer audits.
  • Support relevant training programs.


Requirements

  • Previous experience with clinical management systems and documentation advantageous
  • The ability to respond appropriately to requests from people at all levels of the organization
  • Experience with analysing data and presenting it to stakeholders
  • Proven ability to work across functional teams and global locations
  • Excellent communication skills
  • Excellent time management skills and the ability to self-manage and prioritise work

Job Information

  • Job ID: 59572048
  • Location:
    Amersham, Buckinghamshire, South East England, United Kingdom
  • Company Name: Phlexglobal Limited
  • Position Title: QA Coordinator
  • Industry: Pharmaceutical
  • Job Function: Quality Assurance
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: GCSE/GNVQ/O level
  • Required Travel: 0-10%

Please refer to the company's website or job descriptions to learn more about them.

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