About the Role:
Zenith Technologies is looking to hire a QA IT (CSV) Lead to join our client’s Biopharmaceutical site in Dunboyne, Co.Meath.
QA IT (CSV) Lead will design and manage all compliance activities for the assigned GxP regulated computerized systems throughout each system's lifecycle.
He/She will provide and co-ordinate QA IT oversight and support for the computerised systems that are being implemented as part of a major capital project to ensure compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements. The QA IT (CSV) Lead will actively contribute to the overall validation strategy and liaise with relevant technical and business units to drive consistent and compliant approach across the systems.
• Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports for GxP systems, including but not limited DCS, automated equipment, MES and associated local infrastructure.
• Providing input into the validation strategy for computerised systems, including leveraging approach.
• Liaising with technical and business units to drive consistency and understanding of compliance expectations.
• Ensuring adherence to relevant regulations and company procedures, including DI.
• Providing timely and pro-active QA IT support and guidance to facilitate project timelines.
• Actively working with QA IT colleagues within the site as well as the global QA IT organisation to ensure alignment with the current site and other projects.
• Escalating any potential compliance issues in a timely manner.
Qualifications & Requirements:
* Min. 7 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
* Project experience in a senior specialist / lead position.
* Strong compliance background
* DeltaV, OSI PI and PAS-X experience
* Experience with ISA S95 and S88 standards
* Experience of Testing GAMP Category 3, 4 & 5 systems & knowledge of CFR 21 Part11
* Excellent knowledge of relevant regulations and industry standards.
* Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
* Excellent communication skills.
* Project management experience will be an advantage
Software Quality Assurance (Sqa)
Code Of Federal Regulations
Systems Development Life Cycle