QA CSV Specialist

Job Description:

This leading biopharmaceutical CDMO are continuing to expand their Irish operation by establishing a new state-of-the-art facility in north Leinster. A vacancy has now arisen for a Contractor QA CSV Specialist to join a dynamic and high performing team. This site will manufacture for global supply and is expanding in response to growing customer requirements.

This is initially a 6 month contract with a competitive hourly rate.

Reporting to the Head of QA, the QA CSV Specialist will be responsible and accountable for the correct validate status of computerized systems and inspections readiness of the Modular Lab with regard to CSV.

Essential Duties and Responsibilities

· Responsible for reviewing the existing CSV documentation for completeness, correctness and compliance with regulatory requirements, especially with regard to data integrity (DI) requirements and a consistent requirements traceability matrix (RTM).

· Preparation of assessment reports from the CSV reviews, including gaps and plans for required mitigation measures.

· Update and amendment of validation documentation based on review results. Preparation of risk assessments.

· Update of SOPs for CSV based on identified gaps or insufficiently described processes.

· Prepare documentation for the inspection to explain the roles of global and local functions, and applicable procedures, during implementation and validation of global IT system.

· On-site monitoring of data integrity related activities in the Modular Lab to ensure correct execution and documentation.

· Liaise actively with other functional areas, especially local/global IT and global QA. Actively communicate with stakeholders and report issues within established reporting lines.

· Drive CSV activities from a local perspective and involve other functions actively.

· Actively participate in internal and external audits as SME.

· Perform all activities in compliance with applicable safety standards and SOPs

· Participate in other duties as assigned, e.g. upcoming SAP rollout.