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
* BSc/MSc or BEng/MEng in Engineering or related discipline.
* 7 - 10 years minimum in validation, quality systems, operations, engineering or any combination thereof.
* Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge.
* Experience with managing teams in a GMP manufacturing environment.
* Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
* Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.
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