Quality Technician

Main purpose of job:

The overall implementation and maintenance of the Company's quality management systems.

Main responsibilities:

Preparation / authorisation of Master BPRs, pre-production BPRs artwork, component specifications, labels, Quality Investigations, reprocessing paperwork, calibration records, temperature records, environmental reports etc.
Liaison with customers on issues relating to quality matters
Presenting quality related data and regular quality reviews.
Review of Batch Documentation prior to release; including completion of paperwork, resolution of deficiencies and inaccuracies, reconciliation, preparation of release documentation.
Technical approval of paperwork for the production of supplies
Assist in investigations and decision making relating to operational issues and complaints.
Advising senior Quality personnel of any deviation / non-conformance / abnormality observed with finished product and / or batch.
Administration of exceptions and SCARS to be raised or QA reviewed
Design and maintenance of trial documentation to include SOPs and Standard Documents
Assisting with review of CAPA evidence and completing CAPA effectiveness reviews
Checking and / or approval of randomisation databases
Electronic approval and locking of label set-up
Approval of printing requests for trials labels
Develop / maintain filing systems and the archiving of QA controlled documentation
Support the preparation / review of change controls, PQRs, audit responses, complaint responses, Technical Agreements etc.
Internal auditing for ISO9001:2015 and cGMP compliance.
Liaison with suppliers and supporting / conducting supplier audits.
Assist in preparation of monthly report and other reports as required e.g. client requested information.
Advise on quality related issues during new product introductions.
Lead or be part of team in Continuous Improvement activities.

Vibe Recruit is acting as an Employment Agency in relation to this vacancy.