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Validation Engineer
4 weeks ago
Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for Validation Engineer to join their state of the art pharmaceutical facility.
Located in the historic province of Connacht neighbouring the pond that is the Atlantic Ocean, breeds a mix of Irish culture and modernisation in the popular seaside town rife with bars, restaurants and water sports.
Responsibilities:
Ensure all Computerised 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 Requirements:
3rd level qualification in a relevant engineering or scientific discipline. A minimum of 5-10 years' experience in a cGMP regulated environment. A good understanding of regulatory requirements. Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times. Requires proven problem-solving skills and the ability to adapt to new regulatory requirements. Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis. If this role is of interest to you, please apply now
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