PE Global is currently recruiting for a Quality Control Analyst for a leading multinational pharmaceutical client based in Carlow.
This is an 11-month contract position.
Key Responsibilities:
* Support the Quality Control Department in managing external sample shipments and retaining samples.
* Perform various administrative duties related to sample management.
* Ensure objectives are achieved consistently with MSD's requirements for compliance, safety, and reliable supply to customers.
Specific Job Tasks:
* Act as the point of contact for QC sample and retain management.
* Manage QC external sample management from receipt to shipment.
* Manage QC retain sample management from receipt to disposal.
* Understand current Good Manufacturing Practices (cGMP) related to the QC Laboratory and identify gaps in processes or systems.
* Proficiently use Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
* Proficiently use Lab management software systems (LIMS).
* Prepare documents and coordinate sample movement within the Warehouse area.
* Review e-logs and/or LIMS to align physical quantities of samples in freezers/refrigerators/lean lifts and sample cages.
* Take ownership of processes related to sample handling, such as oversight of freezer/refrigerator clean schedules.
* Investigate sample management-related non-conformances.
* Support internal and regulatory audits.
* Format, write, and deliver necessary documentation according to Merck Global Policies, Procedures, and Guidelines, and regulatory requirements.
* Contribute to continuous improvement through active participation and engagement with the laboratory team during investigations and subsequent corrective actions.
* Ensure timely completion of assigned documents to meet site metric requirements.
* Collaborate to drive a safe and compliant culture in Carlow.
* Participate in QC daily tier meetings and communicate assigned tasks/projects effectively.
Requirements:
* Third-level qualification preferred, ideally in a related discipline.
* Experience and/or a particular skill set in their area of expertise that adds value to the business, preferably in a GMP setting.