My Client is currently recruiting an experienced Quality Specialist to support operations in our state of the art sterile vaccines and biologics manufacturing facility in Carlow. This is an exciting and challenging opportunity ranging from directly supporting sterile manufacturing activities to batch release to market and continuous improvement projects supporting commercial, clinical and new product introductions.
This role will operate on a 24/7 shift rotation basis.
· Responsible for ensuring that the process for the manufacture of drug product at clients manufacturing site in Ireland (Carlow) is in compliance with cGMP and the associated regulatory requirements.
· Responsible for resolving technically complex manufacturing issues with operations in compliance with cGMP requirements.
· Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations. Ensure that objectives are effectively achieved, consistent with MSD's requirements to ensure compliance, safety and reliable supply to our customers.
· Responsible for guiding team members and ensuring shift quality deliverables are met and performance metrics achieved.
· Review and approval of all manufacturing batch documentation including electronic batch records, using the site systems.
· Review and approval of change controls, SOP's, Deviations, cleaning verification/validation data and other documents as necessary for the IPT (Operations) department.
· Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same.
· Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
· Performing as quality lead in complex investigations and corrective action generation ensuring cGMP and regulatory requirements are met.
· Leading group meetings and driving metrics performance for the group.
· Delivery on improvement projects for the quality group.
· Support regulatory inspections by becoming SME on production processes and GMP requirements, presenting to auditors, and closing out audit responses
· Supporting major process changes and tech transfers.
· Work collaboratively to drive a safe and compliant culture in Carlow.
· Work shift patterns in line with manufacturing operations to ensure Quality oversight as required.
· Provide effective real time on the floor support for day to day manufacturing operations for example area clearances, batch record reviews, aseptic operations.
· Provide quality input into decision making process on the shopfloor ensuring that product quality is maintained.
· Provide training in all aspects of Quality Management Systems and GMP.
· Ensure all work is carried out in line with SOP's, training or other quality systems such as change controls where applicable.
· Drive compliance with our 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.
· Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions using the site SAP system as a tool.
· Participate and provide quality input in root cause analysis of system failures and substandard performance ( equipment and personnel), using standard tools and methods, to resolve issues e.g. FMEA, Fishbone diagrams, 5 why's etc, GEMBA's, oversee and implement subsequent corrective action through the change management system.
· Participate in initiatives supporting root cause elimination to improve performance at site.
· Identify opportunities to improve and stream line processes and participate in or lead projects in this area for the quality group.
· Bachelors Degree or higher preferred; ideally in a related Science or Engineering discipline
· Ideally 2+ years experience in pharmaceutical manufacturing environment ideally in a quality role
For more information please call Darragh on 01-6455250 or email