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Quality Assurance Advisor

Location: Northamptonshire
Salary: Competitive
Ref: ALS 2222

On behalf of our client, we are looking to recruit a Quality Assurance Advisor to monitor the status and reporting of studies, as a function independent of the personnel engaged in the conduct of those studies.

Basic Requirements

  • BSc in a life science subject
  • Thorough understanding of GLP/GCP regulations
  • Experience working within a compliance/regulatory position
  • Expertise in auditing, report drafting, SOP review, and resolution of inaccuracies/irregularities

Duties and Responsibilities

  • Act as a contact for Quality Assurance GLP/ GCP enquiries and to advise staff of the specific regulatory requirements as appropriate (recommending suitable solutions where necessary)
  • Conduct reviews of Plans and Amendments for completeness and compliance with regulatory requirements
  • Inspect critical phases of on-going studies and procedures to determine that Plans and SOPs are being followed
  • Perform Process, System and Facility inspections to determine that Plans and SOPs are being followed
  • Perform audits of draft Reports confirming that methods, procedures and results accurately and completely reflect the raw data
  • Conduct accurate and timely audits of the draft Reports according to company Standard Operating Procedures and to promptly report findings to the Study Director/ Principal Investigator/Analytical Project Manager/System Manager and Management
  • Resolve, with study staff as necessary, apparent inaccuracies and irregularities, arising out of observations made during inspection/audit
  • To write and/ or test out proposed and modified QA SOPs with the object of assessing effectiveness and practicality
  • To assist with the training of junior members of QA staff and other members of staff within the company where appropriate

Agenda and its clients only recruit people who are passionate about animal care and welfare, people with integrity who are honest and trustworthy and who have a great work ethic.  To enable us to hire the very best people we will conduct a full and comprehensive background and pre-employment screening as an essential part of the recruitment process.