Job Description
Role To coordinate the development and maintenance of the company’s validation program in compliance with all applicable regulatory and company requirements. Co-ordination, implementation and active participation in the site Validation Program. Responsibilities: * Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements. * Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, * European cGMP and GAMP standards. * Generation/maintenance of the Validation Master Plans. * Generation/maintenance of Project Validation Plans. * Generation of validation plans, protocols and final reports to cGMP standard. * Review / approval of all protocols and final reports. * Management of validation change control process. * Adheres to and supports all EHS & E standards, procedures and policies Supervision Received * Individual is given authority to carry out their duties without close supervision. * Reports to Validation Team Leader. * Goals are reviewed on a regular basis and formal performance reviews are carried out once per year. Supervision Provided * No direct reports. * Provide guidance to functional areas the area of Validation. * May provide cross training and guidance to new department members. Qualifications: * 3rd level qualification in a relevant engineering or scientific discipline. Job/Technical Skills * A minimum of 5-10 years’ experience in a cGMP regulated environment. * A good understanding of regulatory requirements. Ownership and Accountability * The position has a high level of autonomy and individuals are expected to work on their own initiative. * Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines. * Individual is fully responsible for the co-ordination and closure of projects assigned. * This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned and resolved. * This position impacts on product quality and technical performance as well as manufacturing operations. * Requires an ethos of Right First Time at all times. Decision Making/Impact * Expected to provide functional expertise to support daily operations. * Seeks Managers input when making decisions which affect the area. * Is a site SME on validation issues and provides guidance on same. * Decision making within confines of agreed responsibility with Team Leader. For immediate consideration please forward your CV to