Quality Assurance Officer

Preparation / authorisation of Master BPRs, artwork, component specifications, labels, reprocessing paperwork, pre-batch documentation, calibration records, temperature records, environmental reports, MWOs, etc. Liaison with customers on issues relating to quality matters, presenting quality related data and attending and presenting at quality review meetings. Assist with initiating any nonconforming events within the QMS. Advise Senior Quality personnel of any deviation / non-conformance / abnormality observed with finished product or major non-conformance against procedure. Complete minor complaint investigations, identify root cause and robust CAPAs to eradicate reoccurrence of issue. Support with management of non-conformances raised within the QMS. Review and assess Events initiated, ensuring that all events are classified correctly in terms of risk and have been raised in conjunction with procedure. Determine next steps for event (ie raise to NONC or Deviation). Review and approval of deviation reports ensuring that root cause analysis has been completed and robust actions have been identified to eradicate reoccurrence of an issue.