Main purpose of role:
The overall implementation and maintenance of the Company’s quality management systems and adherence to cGMP.
Responsibilities
Preparation / authorisation of Master Batch Packaging Records (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 Qualified Person (QP) release or release of non-licensed products or materials; including completion of paperwork, resolution of deficiencies and inaccuracies, reconciliation, preparation of release documentation.
Technical approval of paperwork for the production of clinical supplies pre and post packaging and in-process sheets for Rapid Response work.
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 within Pilgrim i.e. entering information, reviewing exception content and risk categorisation / SCARS raised, monitoring these non-conformities and seeking closure. Sending exceptions and investigation reports to clients and dealing with any observations.
Design and maintenance of clinical trial documentation to include SOPs and Standard Documents as appropriate and as agreed with operations department.
Assisting with review of CAPA evidence and completing CAPA effectiveness reviews.
Checking and / or approval of randomisation databases to include electronic approval and locking of databases on Prisym labelling system.
Electronic approval and locking of label set-up on Prisym labelling system acting as back up to project management team.
Approval of printing requests for clinical trials labels and additional approval of finished printed labels for print only projects where labels are despatched.
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.
Assistance in other paperwork related functions within the department as required.
Take care of your own health and safety and that of people who may be affected by what you do (or do not do). Co-operate with others on health and safety, and not interfere with, or misuse, anything provided for your health, safety or welfare.
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