QUALITY ASSURANCE TEAM LEADER
Are you looking for a highly progressive role in Cork?
This is a permanent opportunity with a blue chip Bio -Pharmaceutical company in the Cork area. This company are reknowned for on-going development of their employees and take the time to give back to the community
- Supports GMP qualification and validation activities through execution of supplier/contractor audits and directing review of qualification/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
- 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 on the state of compliance.
- Assists Quality Director and QA Managers in management of quality inspections and audits
- 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.
- 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.
- Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
- Motivating and developing reports in addition to developing and setting measurable and challenging goals for the group.
- 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.
Please call Rachel Lane TODAY for more details on 022 46969 or email firstname.lastname@example.org