Aktuelle Jobs im Zusammenhang mit Lead Process Specialist - Langkampfen - Novartis
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Shift Lead Ii
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Process Expert
vor 2 Wochen
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Lead Process Specialist
vor 3 Monaten
Location: Austria, Schaftenau
As a Senior Process Expert, you will be responsible for delivering frontline technical and scientific expertise for all process-related challenges, ensuring timely execution of operations to maintain business continuity. Your role will involve adherence to current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and relevant guidelines and functional standards (e.g., HSE, NOSSCE), while continuously striving for enhancements in quality and productivity efficiency.
Additionally, you will take on the responsibilities of an accountable person ('Herstellungsleiter') for the manufacturing of finished products ('Halbfertigprodukt' and 'Fertigprodukt') in accordance with the regulations set forth in §8 of Arzneimittelbetriebsordnung (AMBO) 2009.
This position will collaborate closely with the Manufacturing Team and report directly to the Process Support Unit Lead.Key Responsibilities:
Your responsibilities include, but are not limited to:
- Deliver expert support in the coordination and production of biopharmaceuticals.
- Facilitate fundamental GMP processes.
- Develop production supporting documents and concepts, as well as prepare for internal and regulatory inspections.
- Provide real-time shop floor assistance as a technical expert, ensuring all production activities are completed on schedule, in line with documentation, and compliant with GMP, SSE, and 5S standards.
- Identify, initiate, and manage improvement projects within the production environment.
- Prepare and conduct training sessions for production personnel on industrial hygiene, GMP, and safety protocols.
- Oversee the execution and interpretation of study results, along with the provision and assessment of process-relevant data.
- Manage deviations, implement and coordinate defined actions, and execute approved change requests.