Summary: 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.
This is a hybrid role.
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 e Validation 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.