Cqv Sme

Summary: Our client is a pharmaceutical company based in East Cork looking for a CQV/CSV SME on an AVI roll-out project at their facility to provide subject matter expertise to vendor and the local AVI project team on site.
The CQV Expert will report to AVI PM for daily activities and ensure the PM has all necessary inputs to effectively deliver the project on Safety, Quality, Schedule, Scope, and Cost.
The CQV Expert will ensure there is strategic alignment by working closely with Vendors, Quality, Validation teams, Business, Automation interfaces both globally and locally on Automated Visual Inspection validation.
During basic design phase the CQV will lead the validation related preparations, design workshops, and ensure basic design is delivered to meet business outcomes.
Responsibilities: Ensure the AVI design is performed without any compliance gaps.
You will act as CQV Owner designee during the project.
You will work as System Owner designee during the project to carry out vendor assessments if required Implement global standards across the project.
Support project planning across the project streams.
Develop relationship with operational users to understand their needs.
Work collaboratively with system integrators to define all validation deliverables, design and deliver them tailored to life science production processes.
Interface regularly and provide formal and informal project status updates to the Project Manager.
Develop and execute equipment and computer system validation plans and strategies Conduct risk assessments to determine validation scope and depth Create validation protocols (IQ/OQ/PQ) and validation reports Manage validation project timelines and resource allocation Create and maintain validation documentation packages Perform system testing and test script execution Investigate system deviations and implement corrective actions Initiate and manage change control processes for validated systems Ensure systems comply with FDA 21 CFR Part 11, EU GMP Annex 11, ICH Q7, and other relevant regulations Establish and maintain CQV-related SOPs and work instructions Qualifications & Experience: Bachelors degree in engineering, computer science, or similar.
Minimum of 5-7 years experience in pharmaceutical equipment qualification and validation is a MUST.
Proven experience in validation of AVI systems is strongly desired.
Experience in Gx P environments and understanding of regulatory compliance in the life sciences industry.

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