Location: Austria, Schaftenau
As a Senior Process Expert, you will provide front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE) and to continuously improving in quality, productivity efficiency.
You will also assume duties and responsibilities as accountable person (“Herstellungsleiter”) for manufacturing of finished product (“Halbfertigprodukt” and “Fertigprodukt”) according to §8 of Arzneimittelbetriebsordnung (AMBO) 2009.
This role will work directly with the Manufacturing Team team and reports to the Process Support Unit Lead.
Key Responsibilities:
Your responsibilities include, but are not limited to:
• Provide front line expert support in the coordination and production of biopharmaceuticals.
• Support of fundamental GMP processes.
• Preparation of production supporting documents and concepts, as well as for internal and regulatory inspections.
• Ensure real time shop floor support as an expert on technical problems and ensuring the completion of all production operations on time, in accordance with the documentation and in compliance with GMP, SSE and 5S rules.
• Identification, initiation, and coordination of improvement projects in the production environment.
• Preparation / execution of training for production personnel regarding industrial hygiene, GMP and safety.
• Technical control of the execution / interpretation of study results as well as provision and evaluation of process relevant data.
• Handling of deviations, implementation / coordination of defined actions as well as implementation of approved change requests.