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James QA

With over twelve years' experience in setting up, implementing and maintaining ISO 9001 Good Clinical Laboratory Practice, ISO 17025 and ISO 15189 Quality Management Systems James QA can cover all aspects of Laboratory Quality Management.

Extensive experience from start-up implementation through to refinement of established procedures.

Services include:

  • Quality Management System Development (ISO 9001, ISO 17025, ISO 15189 and GCLP)
  • Auditing (creation of audit calendars, audit checklists and documentation, risk assessments, conducting audits of facilities, processes, studies, SOPs, protocols and reports) conducted both onsite and remotely
  • Assistance with setting up laboratories and facilities to GCLP, 17025 and 15189 standards
  • Documentation development and review (ISO 9001, ISO 17025, ISO 15189 and GCLP)
  • Gap Analysis
  • Vendor audits/quality assessments
  • Assessment Preparation
  • Q-Pulse configuration and implementation
  • Equipment validation
  • Data Integrity mapping
  • Requirements for UKCA registration of IVDD's

Whether you are looking for a one-off audit or continued support to ensure compliance to your chosen standard then James QA can help.

Areas of Expertise

Auditing, Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Quality Management Systems (QMS), Standard Operating Procedures (SOPs)

Availability to work

Remote, Europe

Contact Details

Charlotte James MBA BSc (Hons) MRQA
24 Millfield Park
Undy
Monmouthshire
NP26 3LF

Mobile:       +44 (0) 7720318636
Email:        charlottejamesmba@gmail.com
LinkedIN:   https://www.linkedin.com/in/charlotte-james-88688778/

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