We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Under minimal supervision, this role will be responsible for one or more of the following activities in QC including sample and data management and equipment maintenance.

Duties:

• Liaise with site Planning, Manufacturing and Inspection regarding ADL manufacturing schedule and required QC testing.
• Liaise with Stability Product Representatives and Product Quality Leads as required.
• Perform routine sample management tasks as per procedures.
• With a high degree of technical flexibility, work across diverse areas within QC
• Plan and perform multiple, complex routine/ non-routine tasks with efficiency and accuracy.
• Report, evaluate, back-up/archive, trend and approve data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents and equipment.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
• Operate and maintain GMP equipment, including responding and management of GMP alarms.
• Introduce new techniques/ Processes to the area, where appropriate.
• Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.
• LIMS data coordination of commercial and import testing lots where applicable
• LIMS lot logging for ADL manufactured lots.
• Provide technical guidance, may contribute to regulatory filings.
• Represent the department/organization on various teams as required. Train others.
• Interact with outside resources.
• Perform general housekeeping in all sample management areas in line with 5S.

• Bachelor’s degree in a Science related field is required.
• 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, where 2 – 3 years of specific sample management/ stability programme experience is desirable.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.