Quality Assurance Officer

Quality Assurance Officer Job Description Template

Our company is looking for a Quality Assurance Officer to join our team.


  • Performing investigations to support CAPA’s, Deviations and Change Controls;
  • Recording and performing Data Verification Checks relating to all calibrated production equipment;
  • Liaising and coaching/mentoring Production Technicians in all matters related to quality;
  • Recording, checking and confirming any pre-printed/batch variable data whilst a process is on line and active;
  • Recording and trending any errors or omissions;
  • Ensure compliance to Good Manufacturing practices;
  • Mentor and train more junior members of the Quality Assurance team in Good Manufacturing Standards;
  • Participates in design of call monitoring formats and quality standards;
  • Management of Investigations (Deviations and Out of Specifications);
  • Conduct self-inspections / internal audits;
  • Review and approve stability reports and analytical records;
  • Management of Standard Operating Procedures;
  • PHCI QA Investigations lead;
  • Implement changes related to IMP licence – including SOPs and removal of those that are IMP specific;
  • Change Control Management.


  • Experience in Batch Release, QP, Quality Assurance;
  • Experience maintaing Quality Systems and resolving any issues;
  • Basic experience in pharmaceutical manufacturing, distribution and control measures;
  • Experience in supporting QP declarations beneficial;
  • Knowledge of inspections and audits;
  • Degree qualified in a relevant scientific field;
  • Knowledge of Quality Management Systems and Regulatory expectations;
  • Experience in the review of operations and processes;
  • Experience in Pharmaceutical API Manufacturing;
  • Some experience of regulatory submission documentation;
  • Experience of change controls;
  • Demonstrable experience in both primary and secondary manufacture;
  • Knowledge and experience in quality assurance and compliance;
  • Good Knowledge of Qualified Administered Systems;
  • Experience using SAP.