Quality Systems Team Lead

Hartley People Recruitment

Waterford

Our client, an established pharmaceutical company are looking for a Quality Systems Team Lead to join their team. This is an opportunity to join an innovative company in a challenging and rewarding role. The Role: Drives compliant execution and management of the Quality Management Systems to include: documentation, training and change control. Evaluate and present Quality Systems data and metrics utilizing quality tools to track trend and communicate performance. Understand and use data, key metrics and statistical methods, quality tools or computer based solutions to improve processes. Ensure automated GxP quality systems are implemented and maintained in accordance with cGMP’s. Coordinates Data Integrity initiatives and oversees the adherence and compliance with data integrity policies and procedures throughout the quality management system. Supports the QS Manager in coaching and mentoring the QS team to ensure professional and personal development of department personnel. Coordinates the activities of the Quality Systems group to create a synergistic approach to goals and tasks. Review and monitor the team organizational capabilities and personnel competencies to ensure that they continuously match the expertise and workload required to deliver business requirements. Proactively examines/review systems and processes, to identify/assess areas for review, improvement, change, or elimination with specific focus in simplifying and standardizing processes. Lead and drive improvements as required. Support the assigned processes during internal and external audits including war room management during regulatory inspections. Conducts internal audits to ensure compliance to regulatory and customer requirements. Responds to and drive/participate in investigations and corrective action implementation for identified quality deficiencies, incidents and possible complaints and the follow-up activities in the GMP departments. Attend a number of cross functional team meetings as a Quality Systems representative. Assists in creating a culture of quality awareness and communicating the quality management system, GMP and associated documents and procedures to all staff. Manages and maintains data bases for the quality system and prepares/assists in preparation of annual reports and quality trending reports. Check own work and that of others for accuracy ensuring that all work is documented and retained thoroughly. To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines. To perform additional team tasks as agreed to support effective running of the Business. Implements performance evaluations for direct reports in conjunction with QS Manager. The Person: A third level education or equivalent work experience in a regulated environment, specifically within a Pharmaceutical Quality Team. Experience managing people and team workloads. Significant experience with desktop and internet-based software applications. Significant experience with automated systems validation. Excellent communication and presentation skills. Focus on quality and detail. Experience of developing and delivering training. Careful planning to achieve accurate and timely results. Ability to define and manage own tasks and schedules. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. For immediate consideration please call Pairic on 051-878813 or email your CV in response to this job posting. Hartley People also recruit for similar roles such as Analytical Chemist, Quality Control Manager, Quality Control Technician, Quality Assurance Manager, Quality Assurance Technician, New Product Development Manger, Quality Systems Manager, Formulation Scientist, Development Technologist. This job originally appeared on RecruitIreland.com.

2612 days ago