The Company
Our client is a Biopharmaceutical Organisation based in Northwest of Ireland. Due to an expansion, they are seeking to bring in a QA Engineer on an initial 12 month contract with scope for an extension after.
The Position
The QA Specialist will be responsible for delivery of Quality Assurance activities to ensure the review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going projects. This key role is an individual contributor role whereby the individual must be a self-starter with professional and academic experience in QA and validation activities. This key role must ensure effective interaction with other departments such as Quality Control, Manufacturing, Engineering and Technical Services.
Key Responsibilities:
* QA point of contact providing technical expertise, feedback and guidance for QA and compliance topics /issues including validation strategy /approach, new product introduction and manufacturing and assist in the resolution of issues commensurate with the level of risk.
* Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
* Review and approval of validation protocols/ reports and related documentation to ensure compliance with current EU regulatory expectations and site procedures.
* Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines.
* Ensure application of Quality Risk Management principles as applicable.
* Act as the QA in QA activities in project work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering, and others.
* Actively contribute to continuous improvement activities.
* Other duties as assigned.
The Person
* Third level qualification in relevant science and/or engineering discipline.
* 5 years minimum experience working in a in a GMP Quality environment.
* Experience in a Validation function with strong knowledge of Project Life Cycle and cGMP.
* Strong understanding of GMP compliance and quality standards.
* Excellent attention to detail and significant document review experience essential.
To discover more about this opportunity please apply online or contact Lewis Murray on +353 87 204 3307 for a confidential discussion.
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