Ipsen in Ireland is represented by a dynamic state-of-the-art manufacturing facility, creating API for our key products.
Due to an internal promotion, we now have an exciting opportunity for a Validation Manager to join our 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 the baseline activity and drive improvement, with a strong CSV and digital knowledge.
The role will also include:
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 Site Master Plan
Lead the validation effort for all Strategic Projects on site
Preparation, review and approval of qualification and/or validation documentation.
Review and approval of third party generated protocols and reports
Review, execution and approval of site acceptance testing (commissioning) activities
Management of Validation deviations
Participate in change control activities
Chair, schedule and minute validation meetings and participate in meetings when required
Preparation, review and approval of 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
To assist colleagues, where necessary, and where qualified, to train other personnel in validation procedures and approaches
To assist or carry out investigations and recommend where applicable the most appropriate course of action
To participate in Root Cause Analysis as required on site
To enhance the quality of the qualification and validation approach on site
To participate in site strategic management of projects
To deliver on validation timelines relating to Strategic Projects on site
Responsible for the adherence to our Site Safety Culture
To be considered for this role, you will have a 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 then don’t wait, apply today, we’d love to hear from you!
