What you need to know:
A fantastic opportunity has just come in for a QA Assistant to join a leading multinational pharmaceutical company based in Co. Offaly. This is an initial 12 month contract role that offers the successful candidate an opportunity to gain valuable experience with a global market leader along with an excellent salary.
Your new job:
As a QA Assistant you will report to the Quality operations Manager on site. You will take an active role in documentation control activities, archiving and tracking of all non-conformances and quality events or issues. Your responsibilities will include:
- Filing and archival of documentation and support setup of Archival process
- Electronic Quality Management System (Veeva Vault) administrator
- Assist with the training of all personnel in the use of the EQMS & Learning management system (LMS)
- Issuance and control of BMRs, batch documentation and labels. Issuance of controlled documentation for all departments
- Control and review of site training files
- Partake and contribute to internal audits and monthly Audit readiness inspections
- Buffer and media manufacturing record review and SAP release
- Partake in the review of batch records for Cell Culture operations and Purification operations to ensure compliance with the requirements of cGMP and the validated process. Participate in QA review of batch processing
- QA review of QC data, compilation of data for regulatory submissions and you will assist the QA documentation control centre.
- Electronic Tracking System (ETS) QA support
- Co-ordinate change management and CAPA systems
- Provide support to Equipment qualification and validation activities
- Manage specific projects that may arise in a timely and efficient manner
What are we looking for?
- You will have a bachelor’s degree in a life science discipline
- You will have excellent analytical, computer and technical skills.
- You will have experience working in a GMP environment
- You will be self-motivated and have excellent time management skills.