Senior QA Specialist - Cork

We are currently working with one of the largest biotechnology companies globally, with a revenue of $22bn and over 10,000 employees globally. They are currently looking for a QA Specialist to work on a 12 month, fixed term contract to be based at their manufacturing facility in Cork. 

Responsibilities include: 

• Acts as the day-to-day QA project contact person for the Manufacturing and Engineering departments providing guidance / feedback on quality issues related to their respective area project activities. 
• Completes the review/ approval of Manufacturing and Engineering project documentation - in particular equipment/ process/ automation validation documentation. 
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. 
• Actively contributes to continuous improvement initiatives. 
• Builds and maintains good working relationships with Engineering, Manufacturing and Quality department personnel in particular. 
• Supports the preparation for regulatory and customer GMP inspections of the site in addition to performing and co-ordinating internal audits. 
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations to ensure they are implemented and accurately documented in a timely manner. 
• Participates in developing Standard Operating Procedures (SOP’s) to ensure quality objectives are met. 
• Participates in site cross-departmental teams as the GSIUC QA representative - Attending associated meetings ensuring QA is represented & its concerns/ issues communicated, aiding in the identification of potential improvements and participating in discussions on issues/ queries on the associated systems/process. 
• Assists with the maintenance of programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs). 
• Ensures compliance with all site safety-related procedures and practices. 

Experience Needed:

• Experience in the review/ approval of Validation documentation essential. 
• Demonstrates proficient knowledge of FDA/EMA regulations, guidances and current Good Manufacturing Practices (GMPs). 
• Demonstrates proficiency in MS Office applications (including Word, Excel and Power Point, Adobe, SharePoint) and ability to quickly learn new systems is required. 
• Demonstrates ability to work effectively in a team environment, contributing with a positive and constructive attitude. 
• Demonstrates solid verbal, written, and interpersonal communication skills. 
• Must be able to exercise judgement within generally well-defined and established procedures and practices to determine appropriate action(s). 
• Demonstrates independent action and initiative in resolving issues. 
• Demonstrates ability to prioritise and meet deadlines. 
• LEAN and Six Sigma philosophy are embedded in your day to day working.