Description
The Role - Quality SpecialistType - start as soon as possible until the end of 2015
Location - Co. Tipperary
Our key client, a global pharmaceutical leader, is in need of a Quality Specialist, to support their API and New Product Formulation areas of one of the facility in Ireland.
Key Responsibilities:
• The QA Specialist will be responsible for all aspects of Quality Assurance including internal auditing, annual process reviews, ensuring compliance with regulatory requirements, review of pre- and post-processing documentation, review of validation and qualification documentation, GMP and compliance training and will also be involved in leading quality improvement projects.
• The position involves participating as functional expert in the cross functional team that manages production of API / Formulated Products.
• Investigation and approval of deviation events, support of Laboratory out of Specification investigations and identification of appropriate CAPAs.
• Participating in the site audit system by conducting system and walkdown audits.
• Conducting pre and post review and approval of Process and Cleaning Records.
• Preparation of Annual Product Reviews is also a key aspect of the role.
Key Requirements:
• Bachelor or Master's degree in a Science or Engineering discipline.
Experience in one or more of the following areas in the pharmaceutical/chemical industry is required:
• Quality function
• Laboratory Analytical function
• Product development
• Technical services
• Demonstrated leadership and teamwork skills, excellent analytical and problem solving abilities, proven written and verbal communications skills