Overview
Ipsen in Ireland operates a state-of-the-art manufacturing facility responsible for creating API for our key products. Due to an internal promotion, we have an exciting opportunity for a Validation Manager to join the Quality team based in Dublin.
The Validation Manager will ensure qualification and validation of equipment, facilities, utilities, automated systems, processes and process cleaning procedures are carried out in accordance with IMIL procedures and policies, cGMP and relevant guidelines. They will challenge baseline activity and drive improvement, with strong CSV and digital knowledge.
Responsibilities
Site subject matter expert on Computer System Validation, Cleaning Validation, Process Validation, Equipment Validation, Data Integrity and Facility Qualification.
Lead the preparation, review and approval of the site validation master plan.
Develop Validation Plans to support the Site Master Plan.
Lead the validation effort for all Strategic Projects on site.
Prepare, review and approve qualification and/or validation documentation.
Review and approve third party generated protocols and reports.
Review, execute and approve site acceptance testing (commissioning) activities.
Manage Validation deviations.
Participate in change control activities.
Chair, schedule and minute validation meetings and participate in meetings when required.
Prepare, review and approve standard operating procedures and policies.
Perform periodic reviews of systems to maintain validation status.
Comply with all IMIL procedures including safety procedures.
Engage in additional activities as deemed necessary by the Director of Quality.
Assist colleagues, where necessary, and, where qualified, train other personnel in validation procedures and approaches.
Assist or carry out investigations and recommend the most appropriate course of action.
Participate in Root Cause Analysis as required on site.
Enhance the quality of the qualification and validation approach on site.
Participate in site strategic management of projects and deliver on validation timelines relating to Strategic Projects on site.
Be responsible for adherence to the Site Safety Culture.
Qualifications
BSc in Science/Engineering.
At least 5 years in a Senior Validation Role or Senior Quality/Engineering Role within the Pharmaceutical Industry or equivalent.
If you are looking for your next challenge, apply today. We’d love to hear from you.
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