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Details

Quality Assurance Team Leader


Reference:AEYC-673507 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Quality Assurance Team Leader
Our Client, a global biopharmaceutical organisation are currently recruiting for a Quality Assurance Team Leader to join their team on a permanent basis. The QA Team Leader will be responsible for managing the compliance activities and QA operational activities related to as required by Good Manufacturing Practice (GMP).

Responsibilities
• Support the GMP qualification and validation activities through execution of supplier/contractor audits and directing the review of qualification/validation documents providing oversight of qualification and validation programs
• Review and ensures the teams’ organizational capabilities, personnel competencies and that the number of qualified personnel continuously matches expertise and workload needed
• Motivate and develop 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 participate 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
• Coordinate 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 of the site. Manage 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

Requirements
• Bachelors Degree in a scientific/technical discipline required, Advanced degree (MS, MBA, PhD) preferred
• 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
• Demonstrated knowledge and application of industry regulations including those of FDA, IMB, EMEA and other authorities
• Experience in direct interactions with regulatory agencies during site inspections
• Experience in auditing of external suppliers, contractors and vendo

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252