Quality Assurance Specialist

Quality Assurance Specialist.
Responsibilities:

• Manage and maintain existing GDP (Good Distribution Practices) and GMP (Good Manufacturing Practices) structures associated with Wholesale Distribution Authorisation Licence.
• Support validation activities, including mapping studies and protocol execution.
• Develop, enhance and maintain the companies Quality Assurance Program, to meet the Best in Class standards.
• Engage proactively with competent authorities and regulatory bodies in order to maintain legislative compliance and establish key performance indicators as required e.g. HPRA, BRCGS, ISO.
• Identify and implement training to ensure proper and efficient completion of all quality functions.
• Use continuous improvement tools to instigate actions for improvements.
• Be the representative for the company, and customer contact on all quality related queries, compliance requests, audits & follow up, customer complaints, quality agreements, and technical agreements.
• Conduct internal audits/self-inspections according to the Annual Audit Schedule.
• Promote the corporate quality culture within McArdle Skeath, promote awareness and reinforce understanding of quality processes and policies, facilitating compliance.
• Manage the Health & Safety, Environmental & Security Policy within the Quality System.
• Maintain compliance and report on temperature monitoring and engage with suppliers of quality related services.
• Champion CAPA requirements of the organisation and proactively engage all stakeholders
• Problem solve using a defined problem solving technique & detailed Root Cause Analysis to ensure timely completion of all corrective actions
• Provide engineering support to operations ensuring consistent application of quality techniques.
• Resolve quality issues by identifying problems, examining solution options, implementing action plans, and providing resources.

Skills:

• Experience in a Quality role within a science/healthcare/ Biopharmaceutical/logistics/food industry/manufacturing.
• Experience in validation / mapping study activities and associated documentation.
• Experience of development, implementation and management of Quality Assurance Systems.
• A working knowledge of using Lean Tools for Continuous Improvement and Waste Elimination
• Good communication, reporting, presentation and analytical skills
• Good interpersonal skills appropriate to all levels in McArdle Skeath as well as Clients, Suppliers and Competent Authorities
• Relevant Batchelor of Science degree or equivalent.
• Internal audit training.