QA Validation Specialist

Overview

Our client, a pharmaceutical company based in East Cork, is seeking a QA Validation Specialist. The successful candidate will support a multimillion expansion project for the quality unit and will report to the Quality Projects Lead.

Responsibilities

• Responsible for local QA support including, but not limited to, review and approval of Q&V documentation.
• Ensuring that the QAV/QC/QA deliverables are achieved in line with the project schedule.
• Ensuring that the site and global procedures and processes are managed and adhered to while ensuring the ISPE Verification guideline for the project are followed.
• Manage the co-ordination and workload of assigned deliverables for the QA stream.
• Participate in equipment, process and/ or design FMEAs.
• Provision of CSV compliance expertise and review and approval of CSV documentation.
• Identify current and anticipated requirements for compliant facility & utility systems within the manufacturing environment.
• Provide clear communication to all relevant stakeholders where quality related challenges are envisaged and provide quality SME support to proactively drive solutions within a cross-functional, customer-orientated environment.
• Prepare data/ presentations and attend review meetings.
• Approval of GMP related documents within the project.
• Ensure that current quality standards/ regulatory requirements are interpreted appropriately and implemented in line with project remit.
• Participating in regulatory/ internal audits where appropriate.

Qualifications & Experience

• 3rd level qualification in a relevant Science/Engineering discipline, an advanced degree is preferred but not essential.
• 3+ years' experience as a Quality SME in Qualification/ Validation projects within a regulated pharmaceutical environment.
• Project management experience or experience being a key player in large capital expenditure projects is essential for this role.
• Experience with practical applications of QRM, RBV as per ISPE Commissioning & Qualification guidelines, GAMP 5 and risk-based decision-making is desirable.
• Experience working with eValidation software is highly desirable.
• Working technical knowledge of engineering, utilities, QC, validation and manufacturing systems and ability to hold technical conversations with experienced SMEs in those roles is desirable.