Description
Role - QC Technician- MULTIPLEType - 6-11 month contracts
Location - Co. Carlow Ireland
Role:
The role of the QC Technician is to ensure all samples received are sampled and tested to the highest standards of GMP and safety, to meet customer targets. You will provide ongoing feedback to the QC Lead on testing information and the day-to-day operation of the laboratory and ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers.
Key Responsibilities:
• Complete sampling and testing in a compliant manner to meet customer targets. This will include raw materials, components, intermediates, in process and cleaning samples.
• Ensure timely and effective testing of samples in accordance with Carlow schedules and MMD policies, procedures and guidelines.
• Responsible for ensuring all testing activities comply with cGMP.
• Complete review of incoming receipts and documentation of drug substance shipments.
• Set up sampling systems for incoming material. Responsible for setting materials up on LIMS/SAP. Responsible for generating procedures to support these systems.
• Support and comply with all safety and environmental requirements and initiatives on site.
• Responsible for visual inspection of primary packaging component.
• Aid in the resolution of quality issues and OOS investigations which may arise during testing.
• Ensure continuous feedback to QC Lead on issues and problems that may arise.
• Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Participate in effective writing/revising/ rolling out of accurate operational procedures, training documents and procedures for various Quality systems; ensure all work is subsequently carried out in line with same. Participate in projects which they are assigned, using lean tools.
• Actively participate and promote best practice and continuous improvement in the Quality Department by active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
• Participate in root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action through the change management system.
Key Requirements:
• Experience and/or a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Laboratory Quality Systems
• Report, standards, policy writing skills required
• Proficiency in Microsoft Office and job related computer applications required
• Understanding of Lean Six Sigma Methodology preferred