QA Team Lead

Pe Global

Cork

PE Global are currently recruiting for a QA Team Lead for one of its clients in Cork. This is a permanent role. Please call Catherine on 0214297900. Responsibilities of the role: Supports GMP qualification and validation activities through execution of supplier audits and directing review of validation documents providing oversight of qualification and validation programs. Reviews and ensures their team organizational capabilities, personnel competencies and that the number of qualified personnel continuously matches expertise and workload needed, to plan for future requirements in the area. Motivating and developing reports in addition to developing and setting measurable and challenging goals for the group. Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained. Actively participates in management of the Quality Department through budget forecasting and preparation, training of staff, and deputizing for other members of the department management team as appropriate. Responsible for QA staff in the development and implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP. Coordinates QA staff in the development and implementation of systems and procedures for external audits and inspection management suppliers and contractors and reporting to plant management. Assists Quality Director and QA Managers in management of quality inspections and audits of the company by external parties. Manages the tracking of commitments arising from audits and communication of information to site management on commitment completion. Gives direction to the QA Group in the execution of their duties. Coordinates the activities of the group within quality to create a synergistic approach to goals and tasks. Domestic and international travel may be required. Education and Experience required: Bachelors Degree in a scientific/technical discipline required. A minimum of 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry. A minimum of 3 years management experience required. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. If you are interested in this position, please forward your CV to catherine.osullivan@peglobal.net or call Catherine on 0214297900. This job originally appeared on RecruitIreland.com.

2284 days ago