Clinical Compliance Quality Manager

45000.00 - 60000.00 GBP Annual + GBP45000 - GBP60000/annum Home Based
17 Mar 2017
30 Mar 2017
Contract Type
Full Time
Just Life Sciences are an Independent Life Sciences recruiter based in Cardiff, providing Permanent and Contract staff to the Life Sciences Sector in Wales and the UK.

We have an unrivalled opportunity for an experienced Clinical Quality Professional with our client, this can be home based and can be located anywhere in the UK. This is a newly created role and will be very hands on in setting up the SOP's etc. for the business

What is key for our client is that you have GCP and the knowledge of this area, you will be personable and self-starter and used to working on your own initiative. You will have the opportunity to grow with the firm and take on additional staff as necessary.

Should you be successful you will be

•Working closely with all functions and supporting the Quality activities and goals for the company across the GXPs e.g. GCP, PV, GDP, GMP, Medical Affairs etc.

QMS SOPs and controlled documents:

•Responsible for the oversight and for the administration, system update activities relating to the management and maintenance of the company's Quality Management System (electronic validated environment) as the Key User.

•Ensure oversight for the Standard Operating Procedures (SOPs). Including tracking, distribution and maintenance of the SOP tracking systems. Inform the Head of Quality of any non-compliances on a routine basis.

•Continued development, innovation and oversight of regulatory required tracking tools and SOPs.

Continual Improvement, support of the QMS, CAPA and Training

•Responsible for ensuring that the business is driven by continual improvement in quality by ensuring appropriate CAPAs are raised, completed and implementation checks are in place.

•Ensuring Training in CAPA awareness as well as other GXP areas are continually assessed and discussed with the Head of Quality and with the other depts.

•Ensure robust and timely completion of trackers to record CAPA, Audit and trending activities.

•Fully engage in regulatory agency inspections e.g. room set up, preparing documents pre, during and post inspection, hosting etc.

•Design and preparation of training presentations and materials, giving training in areas of expertise to external vendors as required i.e. inspection preparation training.

•Keep up to date with GCP and regulatory changes. Sharing this knowledge across the business and into its processes.

•Further develop and maintain the on-site Archiving for QMS documents ensure the index lists etc. are up to date and kept in line with changes in the regulatory environment

Audit Support

•Ensure that the assigned auditors either internal or external receive the required relevant documentation prior to their audits in a timely manner.

•Ensure oversight for all documentation for the conduct of auditing is stored in the relevant repositories including agendas, draft and final reports, certificates, letters, follow-up documents etc.

•Perform any other activity as may reasonably be required from time to time.

There is an opportunity for Part Time with this role however there will be a small amount of travel involved.

If you are interested in this role then please apply to

justyn withey at justlifesciences dot com