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Quality Assurance Officer

Job Description:

Job Title: Quality Assurance Officer
Location: Hay-on-Wye
Department: Quality
Work Pattern: Rotating Shifts
Reporting to: Senior Quality Assurance Officer
Responsible for (staff): N/A

An opportunity has arisen Quality Assurance Officer within our Quality Assurance (QA) department; focussing on Commercial Quality Assurance. The successful candidate will be responsible for the overall implementation and maintenance of the Company’s quality management systems and adherence to cGMP.

The successful candidate will have the ability to prioritise tasks and work deadlines, along with good administrative, organisational and interpersonal skills. The ability to work in a team and as an individual is essential.

Essential Duties and 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 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 supplier complaints to be raised or QA reviewed 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 Standard Operating Procedures and Standard Documents as appropriate and as agreed with operations department
  • 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, product quality reviews, audit responses, complaint responses, Technical Agreements etc.
  • Internal auditing for ISO9001:2015 and cGMP compliance.
  • Assisting / Hosting / supporting client / regulatory visits / audits.
  • 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.

Requirements:

Qualifications:

Required

  • Science based degree (or equivalent qualification).
  • Proficient utilization of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy.

Preferred

  • Relevant experience within a pharmaceutical company or in a quality role
  • Experience of dealing with customers and / or suppliers
  • Internal / supplier auditing

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