Quality Investigator I / Associate Quality Investigator

at  RoslinCT

QUALIFICATIONS

• A degree in a Life Science degree or equivalent relevant experience.
• For the Quality Investigator I position, Yellow Belt certification in Lean Six Sigma tools is desirable.

• An exciting opportunity for an Associate Quality Investigator/Quality Investigator I to join our team. The level of the position will be dependent on experience.
• You will be responsible for performing detailed and thorough investigations of non-compliances by closure date including product impact assessment, systematic root cause analysis, and identification of effectual corrective and preventative actions.
• Conduct and summarise technical deviation/incident investigations, translating complex operational events into understandable and cohesive summary reports.
• Analyse each event and assess impact in the context of the sterile medicines’ cGMP regulations.
• Gather data from across the organisation, lead and perform root cause analysis to determine the most likely cause.
• Identify realistic by effectual corrective and preventative actions.
• Perform ‘in the field’ investigations, collecting data and interviewing involved personnel.
• Ensure timely completion and closure of deviations and investigations.
• Plan, execute, and lead RCA events with attendance from relevant departments.
• Work closely and collaboratively with operational departments to identify appropriate actions and facilitate deviation closure.
• Train and coach relevant operational personnel to develop their technical writing and investigation skills.
• Partner with Manufacturing Management and Trainers to conduct sharing sessions with operators on investigation outcomes, impacts, and CAPAs.
• Evaluate trends and work proactively and collaboratively on targeted initiatives to reduce deviations.
• Input into other quality management work such as Change Controls, Risk Assessments, FMEA, document updates and CAPA implementation.