QA Manager (Pharma)

Just Life Sciences
Cardiff (Caerdydd)
From £40,000 to £50,000 per annum
07 Oct 2016
20 Oct 2016
Contract Type
Just Life Sciences are recruiting for a talented and experienced QA Manager who is looking for a new challenge within the Pharmaceutical Sector. A role with real impetus into the set up and development of the QA function for the new facility of this Global business Your role will be to take responsibility for QA within GMP and manage the QMS. Having oversight of the GMP status of the facility, and all major operational programmes, both internal and external and will be expected to pro-actively monitor these programmes for compliance, working closely with CMOs, providing quality oversight and managing the technical agreements . Your responsibilities will include the preparation of regulatory dossiers providing advice on the presentation and analysis of data and audit of final reports. The GMP QA Manager will have responsibility for GMP procedures and systems to ensure that they meet the Company’s changing needs and coordinating training to ensure compliance. This will extend to auditing suppliers, ensuring that specifications are agreed for supply of materials etc, that these are consistent with regulatory requirements and that procedures operate to monitor compliance. Conduct contractor selection, for cause and routine monitoring audits of GMP service providers. Building effective working relationships and overseeing the closure of CAPA plans. Oversee the QA input into operational activities. Assessment of changes and deviations so as to maintain regulatory compliance and identify continuous improvement initiatives through CAPA plans. Work with the Head of Quality to establish and continually evolve the Quality culture to meet the Company’s rapidly expanding research programmes and development programmes that offer major regulatory challenges. Ensure that appropriate quality audit is applied to CMC submissions, data, procedures and reports (both internal and external) such that they are suitable for inclusion into regulatory submissions and in turn to critical sections of regulatory submissions. Working with the other departments to ensure the facility operates to GMP. You will be currently a Head of QA or an Assistant who is looking for their next step, yet can offer a wide range of skills in People Management Internal and External Client Engagement GMP and sourcing relevant equipment If you are interested in this opportunity and have the relevant experience then please email your cv to justyn withey at justlifesciences dot com This job was originally posted as