Job Description Summary The Process Support Unit Lead leads the process unit team in coordinating and planning of all activities with end-to-end manufacturing responsibility (logistics, project work, operational excellence, resources and budget/costs) in a way that is consistent with a culture of self-direction (empowerment and
accountability).
Ensures full compliance with quality, Health, Safety and Environment (HSE), Good Manufacturing Practices (GMP), customer service, statutory, regulatory and Novartis requirements.
Job Description
Major accountabilities:
Transmits knowledge, skills and information to members of his team on objectives, problems, performance indicators, values and behavior
Monitor compliance activities necessary for the release of batches produced in
compliance with the defined dates.
Ensure that the processes remain consistent with good manufacturing practices (cGMP) and apply the rules and regulations for safety, health and the environment.
Ensure the appropriate management of the quality events within the appropriate
timeframe (escalation, description, investigation of the cause, evaluation of the impact and criticality, etc.).
Ensure the availability of appropriate operational expertise resources in order to
maintain the validated state of the manufacturing processes in the unit as well as the qualified and validated state of the equipment in the area.
Provide necessary support for the preparation and submission of regulatory dossier (in the context of transferring new products or variations of existing products / processes), and in answering questions from health and safety / environment authorities.
Manage the preparation, execution and follow-up of internal and external audits and GMP and HSE inspections.
Manage the production documentation flow within the production unit (SOPs; MBRs; Forms etc).
Ensure overall inspection readiness for area of responsibility.
Participate to the definition of the operational improvement strategy and the portfolio of continuous improvement projects.
Plays a key role in the prioritization of improvement actions based on available resources.
Essential requirements:
Scientific or Engineering degree.
Previous solid experience within the manufacturing/QA/engineering department of a pharmaceutical company.
People management skills.
Proficient in Italian.
Fluent in English.
Skills Desired
Assembly Language
Change Control
Chemical Engineering
Chemistry
Continual Improvement Process
Efficiency
General HSE Knowledge
Good Documentation Practice
Knowledge Of CAPA
Knowledge Of GMP
Lean Manufacturing
Manufacturing Process
Manufacturing Production
Process Control
Productivity
Risk Management
Root Cause Analysis (RCA)
Scheduler
Six Sigma
SOP (Standard Operating Procedure)
Team Work
Technology Transfer
Web Methods Flow
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