At LEO Cork, we strive to create work environments that foster people management, development, engagement and collaboration, enabling us to build on LEO Pharma’s unique culture. Our people exhibit excellent teamwork and with a family like approach, are united in finding solutions. We provide our employees with the opportunity to increase the depth of their day to day responsibilities to enable flexible, cross functional, successful teams. At LEO Cork, we reward and recognise our people in a value adding way.
The Role
LEO Pharma Cork are currently recruiting a Senior Validation Specialist to join our team. This is a permanent position reporting to the Engineering Manager.
This position provides SME support and management of C&Q and validation activities at LEO Pharma Cork in order to assist internal stakeholders to meet current cGMP regulatory requirements (EudraLex Rules Governing Medicinal Products in the European Community Volume 4 and Annex 1-18, ICH Q7A) and Company procedures as per HPRA expectations.
Responsibilities
- Maintain and Improve the commissioning, qualification and validation systems within the company
- Assist with risk assessments/change controls and deviations by providing input as a subject matter expert on behalf of validation
- To assist and advise the validation of new/existing facilities, utilities, equipment and processes and liaise with production, QC and maintenance on qualification & validation scheduling
- To review and evaluate URS/FS/SDS/HDS/FAT/SAT documents and reports to ensure a good design basis is established for all validation studies
- Generate, review or execution of VMP/DQ/FQ/IQ/OQ/PQ/ protocols/reports for equipment, facility, utility, process & computerised systems.
- Create/maintain site validation master plan or validation project plans as necessary
- Manage external contractors in accomplishing validation project tasks where required
- Create/maintain validation/engineering department related SOPs and WI documents
- Implement and complete engineering/validation related CAPA and deviation actions
- Use site Quality Management System software,
- Maintain knowledge of current validation cGMP practices as per HPRA and EMA.
- Implementation of the Cleaning Validation program within the company
- Implementation and co-ordination of the annual re-qualification studies i.e. temperature mapping or air quality testing executed by external contractors.