Senior Quality Manager

Pe Global

Waterford

Senior Manager, Quality. Responsibilities. Driving the quality systems to maximise the potential of the sites as a first class partner to our clients. Responsible for the penetration of the system throughout the company. Responsible for the compliance of the quality system to the various standards and directives to which the sites operate – cGMP, ISO 17025. Design and continuous improvement of the quality functions, including internal audits, supplier quality management, change control, documentation control, deviations, quality of data, electronic systems. Review of the quality system and scheduling, chairing and implementing the actions from the annual quality reviews. Responsible for facilitating client audits and regulatory inspections, managing CAPA and all correspondence to the clients or regulators in this regard. Responsible for maintaining the controlled substance licence status and complying in full with the requirements for possession of controlled substances. Responsible for the Metrology function across the sites – ensuring that schedules for calibration and qualification are maintained, and co-ordinating unscheduled metrology work. Be the management representative for the regulatory bodies, and the point of contact for informing them of any site changes or variations to licences or certificates. Responsible for development of the Quality Team, driving progression, training and improvement of processes within the team. Ensure the Quality Team are cross trained adequately to ensure all functions are resourced adequately. Keeping up to date with regulatory updates and applying those updates to the quality systems and providing training / briefs to others necessary. Maintain a set of metrics which are gathered and presented to senior management on a regular basis in order to measure the performance of the system and the quality performance of the sites in terms of quality. Education / Qualifications. A qualification to degree level in a science discipline is preferred. A qualification in Quality Assurance, including internal auditing is preferred. Experience / Skills. Experience within a laboratory / QC environment. At least 7 years within a QA role, preferably with 2 of those at management level. Good knowledge of standards and regulations – ISO 17025, EU and US GMPs, ICH. Ability to work independently or as part of a team. Excellent report writing, communication and organisational skills. Quality oriented with the ability to consistently work to industry and client standards. Positive and tenacious approach to work. Highly organised, methodical and systematic approach to work. Passionate about quality and customer service. Good communication skills both internally and externally. Ability to understand customers’ requirements and to be able to devise and articulate the most appropriate solutions. Interested candidates should forward an up to date CV to aoife.lomasney@peglobal.net or call me on 021 4297900 ( comprehensive job spec available on request. 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. This job originally appeared on RecruitIreland.com.

2024 days ago