75,000 - 80,000
3 months ago
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.
- 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 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.