Quality Assurance Officer Job Description Template
Our company is looking for a Quality Assurance Officer to join our team.
Responsibilities:
- 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.
Requirements:
- 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.