- A new opportunity has arisen for a QC Documentation/Administration Specialist at our client’s pharmaceutical site in Co. Dublin.
- The successful candidate will be responsible for supporting the Quality Control Department in the management of department documentation, and support of the QC functions through various administrative duties.
- The individual will ensure that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety and reliable supply to their customers.
Core Duties and Responsibilities:
- Supporting the management of QC documentation including archival of executed protocols, true copy of executed protocols/reports/documents, authoring/updating QC SOP’s and data compilation/review and data verification as directed
- Support for preparation of trend reports
- Coordination and management of QC eLogs
- Support for 5S, housekeeping and audit readiness for QC Labs
- Placing purchase orders for non VMI QC lab reagents and coordination/payment of associated invoices
- Management of purchase orders and associated activities related to budgets and expense reporting
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
- Responds to non-standard requests from customer needs.
- Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
- Use standard systems including MS Word, Excel, PowerPoint, Outlook, SAP and various company and industry specific software such as document tracking, work order entry/tracking, procurement, manufacturing entry/reporting, etc.
- Lead daily tier meetings, and coordinate bi-weekly departmental updates
- Scheduling, coordinating and monitoring appointments for department managers
- Monitoring of department training due dates in Learning Management System (LMS) and supporting system/training requests.
- Coordination of QC Training curricula and manage and maintain area curricula builds
- QC designee for Learning and Development (L&D) site meetings
- Communicate L&D topics and updates at area weekly tiers/meetings
- Managing learning plan matrices updates when new learning identified (confirming impacted job roles & assignment) e.g. new SOP/WI resulting in new learning in area/cross functionally.
- Attend weekly L&D business partner meetings and monthly point of contact site meeting.
- Share L&D information / updates with QC colleagues
- Champion site agile, Learner-centric Learning culture
Minimum Qualifications and Experience:
- Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent
- A minimum of 3-4 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations
- Knowledge of EU/US quality related pharmaceutical regulations
- Basic computer literacy
- Strong communication and organisational skills
- High level of technical aptitude & motivation
- Demonstrated ability to take initiative and attention to detail
- Good presentation skills.
- Excellent knowledge of relevant Quality and GMP Compliance Guidelines
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.