Aseptic Process Owner Lead

Aseptic Process Owner Lead
RK3109
12 Months
Dublin




We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Duties:

• Perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance aseptic operations
• Leading and/or providing input to strategic initiatives that will improve and develop Manufacturing processes for the future including Contamination Control and Aseptic Process Simulations (APS)
• Contribute in a team environment to operational issues pertaining to processes as they arise and provide expertise and support to help resolve escalated technical issues as required
• Remain current on state-of-the-art for systems and processes and advise on the appropriate adoption and use of new techniques and technology.
• Involved in the daily business management systems and reporting, have a clear understanding of what is happening in the assigned area of responsibility. Monitor any process trends (Personnel and Environmental Monitoring), including business performance metrics. Identify actions that will enable the process and the Manufacturing areas better achieve and surpass metrics in the future
• Lead and/or Support investigations that impact on safety, quality and/or compliance of the processes, ensuring thorough investigations are conducted and actionable CAPAs, to prevent future reoccurrence, are implemented within agreed timelines

• Bachelor’s degree in Science, Engineering or related discipline
• 10+ years’ experience in aseptic Drug Product Manufacturing or related cGxP manufacturing
• Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products.