Seeking a highly skilled professional to lead qualification and validation activities in a leading Biopharmaceutical organization.
About the Role
* Design, author, review and approve qualification/validation documentation and cycle development studies.
* Develop, execute and manage change controls.
* Analyse and resolve technical issues encountered during study execution.
* Collaborate with Production, Maintenance and Quality representatives on Cycle Development & Performance Qualification activities.
* Contribute to quality notifications by authoring/reviewing/approving investigations.
* Perform root cause analysis of system failures, substandard performance, using standard tools and methods.
* Drive continuous improvement through Lean Six Sigma methodologies.
* Represent the validation team at global technical forums.
* Ensure compliance of Global Policies, Procedures and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP) in day-to-day activities.
* Support regulatory audits and submissions.
Key Skills and Qualifications
* Proven experience in cleaning validation, including CD & PQ of mobile vessels (CIP) and parts washers (COP), recipe development & optimisation, cleaning verification, cleanability and recovery studies using TOC, ICP & swab methods.
* Considerable experience in a comparable role, operating as an individual contributor in a GMP manufacturing setting, with relevant qualifications/skills:
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, proven track record in delivering excellence.
* Exception / Deviation Management and Change Control.
* Leadership of technical related projects.
* Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
* Equipment and process validation.
* Sterile Fill-Finish processes and equipment.
About Us
We are a leading Biopharmaceutical organization based in Carlow. If you have any questions, please contact us at +353 87 798 8480 for further information.