Our client is an innovative organization who designs & manufacture clean room solutions for the Pharma & Biopharma industries. They have offices & manufacturing capabilities in both the US & Ireland. They are seeking a Quality Lead for their manufacturing in Kilkenny in Ireland. The successful person shall be involved in all inspection, testing, and commissioning activities throughout the product design, manufacturing and testing phases. The Quality lead will be responsible for following company procedures to ensure that our client provides a consistent and satisfactory product to customers across EMEA.
Quality Control Oversight 25%
• Performs inspections continuously throughout the build phase on all projects manufactured in Ireland.
• Performs inspections of incoming critical materials to ensure that there is no damage.
• Follows standard inspection forms and documents all testing.
• Provides feedback to project leads on issues that have come up.
Quality Assurance Oversight 25%
• Generate Non-Conformances and lead Root Cause Analysis for issues that have a severe negative impact.
• Supports development of site-specific procedures and documentation.
• Reviews pharmaceutical best practices and regulations to ensure products meet all regulatory requirements.
Commissioning Documentation Generation 25%
• Creates test procedures to confirm design and installation of all mechanical, electrical, process equipment and Automation System.
• Verifies that all equipment used in the product meets industry standards.
• Develops Commissioning Strategy, FAT, and SAT documentation for each unit.
• Creates punch list to track items requiring correction.
Commissioning Execution 25%
• Travels to job sites, interacts well with customer (Up to 40% of the time to various suppliers, collaborators and client sites)
• Executes FAT and SAT
• Leads Commissioning activities.
• Follows Good Documentation Practices to ensure that tests performed are clearly and legibly documented.
• Documents any discrepancies/deviations that occur during testing.
• Performs Root Cause Analysis of issues and works with a multidisciplinary team to facilitate the correction of issues.
• Follows customer SOPs in gowning and performing testing in pharmaceutical cleanroom environments.
• Performs on-site training of customer personnel so that each customer can maintain the units.
• Bachelor degree in: Construction Science, Engineering, or practical ﬁeld construction background
• Experience in controls for HVAC systems, including familiarity with current technology, both conventional and direct digital control
• Experience working and knowledge pertaining to Pharmaceutical Cleanrooms
• Knowledge of HVAC systems, covering design, common control strategies, installation, operations and maintenance
• Knowledge of Commissioning according to cGMP standards.
• Skill in authoring test protocols
• Skill in basic computer functions such as word processors, spreadsheets, and internet usage
• Up to 30% Travel
• Demonstrated ability to organize many speciﬁc activities into a coherent commissioning plan
• Experience working with multi-disciplinary teams
• Ability to make decisions and recommendations
• Ability to demonstrate professionalism with personnel and management
• Collaborative team player
• Ability to gather, organize and analyze information skillfully
• Ability to manage multiple projects concurrently
• Must be able to communicate effectively through oral and written communication
If you would like further Information you can contact the recruiter directly:
Karen Shiel | Tel: +353 (0) 1 5079256