To prepare the site to receive audits and inspections from external regulatory agencies, certification bodies and internal inspectors
To coordinate the implementation of the requirements within the quality standards and ensure quality systems remain current
To co-ordinate the site quality performance metrics
Minimum qualifications/certification required for this job
Minimum 3 years experience within a quality unit
Prepare and maintain site self inspection schedule. Ensure self inspections are performed as per schedule and are documented. Follow up on completion of the action plans
Prepare the site to receive audits from external bodies e.g. MHRA, FDA, BSI and FAMI QS. This includes scheduling and chairing audit readiness meetings, performing self inspections of areas involved, ensuring key contacts and documentation is available, running the back room and/or acting as scribe
Coordinate changes to and implement requirements from global quality standards (LQS&CQS); assist in gap analysis and identify and evaluate actions to achieve compliance to standards
Ensure site performs effective quality management reviews by:
Develop and implement QLT schedule. Generate and lead presentations on a monthly basis at QLT. Highlight any quality related issues or trends.
Develop annual quality system reviews.
Reporting on site quality metrics.
Responsibility for site compliance reports, periodic updates to corporate on site quality systems
Manage site quality plans
Involvement in site and global projects as required
Provide support to other areas in the quality unit as required
Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert