Purpose

Responsible for supporting the Quality Control Department in the management of laboratory GMP documentation, and in supporting the various administrative duties. Ensuring that objectives are effectively achieved to, consistent with company requirements to ensure Compliance, safety and reliable supply to the customers.

This is a day role, Mon-Friday based on site.

Responsibilities

Be a document system expert for the Quality Control Department; this will include document generation and review and document system work-flow expedition where applicable – examples include Standard Operation Procedures, Work Instruction, Policies, Safety procedures, Annual Product Reviews, electronic logs.
Format, write and deliver necessary documentation in line with company Global Policies, Procedures and Guidelines, regulatory requirements.
Support laboratory administration activities through documentation generation, documentation filing, tracking and auditing.
Manage and complete department specific assignments, including periodic review of documents.
Support continuous improvement by active participation and engagement with laboratory team for document updates out of investigations and corrective actions.
Contribution to Kaizen events and documentation improvement projects as appropriate.
Ensure timely completion of all assigned documents to meet site metric requirements.
Work collaboratively to drive a safe and compliant culture on site.
Participate in QC daily meetings and ensure effective communication of assigned tasks/projects etc.

Requirements

Degree 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 GMP setting.
Proficiency in Microsoft word, Office, excel and electronic data management systems
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
Report, standards, policy writing skills required
Understanding of Lean Six Sigma Methodology preferred