Validation Manager

Job Description

A Validation Manager is required by Careerwise recruitment to work with a Co. Clare based pharmaceutical industry client.

Role of this position

• Generation / Update of the site Master validation plan.
• This role will be the key participant during site audits and inspections and must be able to clearly understand and explain all site Validation activities to regulators.
• Interface with other departments such as Engineering, QC, System Users. System Owners, process, Automation / CSV, Warehouse, QA, QA Validation and Manufacturing to ensure that validation project plans are understood and in keeping with site objectives.
• Generate, review and approve validation, qualification, plans, protocols and reports or assign designee.
• Understanding of cGMP, good engineering practices and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
• Interface with external consultants, suppliers and contractors to ensure successful utility and equipment validations are executed per agreed deliverables and managed within approved PO budgets.
• Write or assist in writing / reviewing of Validation Policies, Validation SOPS / Templates for site.
• Coordinate, track and report all Validation and qualification activities across projects and routine operations.

JOB REQUIREMENTS