This role is fantastic new addition to a dynamic, ever evolving and multi-product site. Reporting in the AD of Quality, the Validation lead will be responsible for oversight and management of the site Process and Cleaning validation function and also the co-ordination of the execution of validation activities (process, cleaning and equipment qualifications) with the relevant departments. Prior people management / leadership experience is required as you will be leading a team of 5.
For the first few months this will predominantly be an onsite role but once settled in there will be flexible working on offer.
A bit more about the role:
- Contribute on the preparation and review of the Validation Master Plan - Process and Cleaning
- Contribute to the management of the validation requirements of the site and third party suppliers and CMO's
- Manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation)
- To maintain and take responsibility for the cleaning validation strategy
- Contribute to the management and responsibility of the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU
- Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications
- Responsible for the execution of Risk Assessments or Investigation reports relative to the role
- Maintaining validation documentation system
- Publish Monthly Validation Metrics on KPI
- Required to Lead cross functional teams providing knowledge in resolution in any technical issues
- Assisting in the preparation and hosting of associated regulatory and customer audits
Key Requirements:
- Sc. / M.Sc. in Scientific Discipline
- Minimum 5 years relevant experience in a Validation discipline i.e process, cleaning or equipment
- Demonstrated ability to work and communicate effectively cross-functionally with at all levels of management
- Proactive, motivated, analytical and strategic thinker.
- Hands on people leadership experience
If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
