QA Specialist

Job Type:
Job reference:
26 days ago

QA Specialist

Full Time


About the role:

We have an exciting opportunity for a QA Specialist to join a world-leading CDMO.

Using your experience as a QA Specialist, you will be:

  • Responsible for ensuring that a compliant quality system is maintained.
  • To maintain and support the eQMS.
  • Responsible for ensuring GMP and GDP compliance and best practice within all such regulated activities.
  • Assist in maintaining a solid Quality culture throughout the UK and EU.
  • Provide day-to-day support for business-wide quality enquiries.
  • Support the Quality staff to ensure GxP Training is up to date and assist with SOP training.
  • Assist in the creation, maintenance and archiving of GxP documentation.
  • Contribute to deviation investigations and follow up on CAPAs to ensure timely close out of actions.
  • Log Complaints and support timely investigation and record resolution.
  • Provide support during MHRA and Health Authority inspections.
  • Supports QA team in achieving team goals/targets
  • Support the site's compliance improvement plans, including proposing new ideas to improve/influence Site and Quality performance, efficiency, and compliance
  • Support product and process monitoring by participating in trend reviews, e.g. CPP, CPA, deviation trend reviews, laboratory errors, and environmental data. Highlight any areas of concern and assist in their resolution, commensurate with the risk
  • Perform critical /constructive reviews of procedures, processes and ways of working

The role is an excellent opportunity to utilize your QA Specialist experience in an innovative industry and progress through a successful career in the aerospace sector. My Client provides full training and career development opportunities.

What experience do I need?

You will need knowledge of GMP and GDP.

We would also require an understanding of the following:

  • Knowledge of GMP and GDP.
  • Detailed knowledge in Good Documentation Practice and Data integrity
  • Practical experience in GxP Quality Assurance.
  • Proactive and solutions-driven, with the ability to work to strict deadlines with a high level of accuracy.
  • Competent knowledge of risk-based approach, used in deviations and risk assessments
  • Degree in Quality Management, life sciences or a related field (desirable).
  • Excellent communication skills: verbal and written.
  • Ability to communicate effectively at all levels of the business.
  • IT is literate: Microsoft Outlook, Word, Excel, eQMS (Q-Pulse desirable).
  • Highly self-motivated with strong interpersonal skills.
  • Effective planning and time management, organizational.

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