Quality Assurance Specialist


Competitive

REF: 0062

Are you an experienced QA professional looking for an opportunity to development your career in a highly-respected Contract Research Organisation? Do you have proven experience maintaining compliance to GLP regulations?

Key Information

  • South East
  • 01423 813520
  • Full-time
  • 20-12-2017
  • Competitive
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Job Description

Our client, a highly successful and respected CRO, is looking to recruit a Quality Assurance Specialist to provide inspections to ensure all studies are conducted in compliance with Good Laboratory Practice (GLP) Regulations.

Key responsibilities include:

  • Review study plans for GLP compliance and consistency. Attends pre-study meetings and schedule critical phase inspections with all levels of study staff.
  • Perform critical phase inspections to monitor for GLP, study plan, & SOP compliance, and reports findings to study directors and management.
  • Audit entire files and final reports for GLP compliance.
  • Perform internal facility inspections of all laboratory and supporting areas to assess regulatory compliance, reporting findings to management.
  • Perform external facility inspections of sub-contracted facilities to assess regulatory compliance.
  • Plan and carries out appropriate self-development activities.
  • Train less experienced staff in various aspects of quality assurance, as assigned and provides input to management for staff performance evaluations as requested.
  • Work with direct reports, contractors and Project Team Leaders to establish work plans related to the auditing of GLP studies.
  • Ensure the on-time compilation, review and submission of QA documents (e.g. audits, CAPAs).
  • Tracks KPI’s for departmental objectives and report to Project Leaders on a monthly basis.
  • Provide input to the development of the QA Unit through related SOPs and other critical and essential QA facility documentation.
  • Keep abreast of changes to global regulations and guidance documents.

The ideal candidate will be educated to BSc level or above in Chemistry or related discipline with previous experience of GXP Quality Assurance, preferably in preclinical GLP. You will be capable of demonstrating a solid understanding of the regulatory framework, international requirements, legislation, and processes and procedures related to pre-clinical safety studies conducted to GLP. You will have a proven ability to work calmly under pressure, delivering quality work within agreed time & resource targets.

In return, you will be compensated with a competitive salary and benefits package. This is an organization that truly values their employees as evidenced by their impressively low staff turnover.

For more information or to apply, please contact Zara Jackson on 01423 813520 or alternatively send your CV to zara.jackson@networkscientific.co.uk.

Please note that all applicants for this role should be able to prove that they are legally entitled to work within the UK. Network Scientific Recruitment, part of Network Scientific Ltd. is an Employment Business/Agency.

To be considered...

Travel required for external audits.

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