Process Support Unit Lead

2 settimane fa

Torre Annunziata, Campania, Italia Novartis A tempo pieno 60.000 € - 120.000 € all'ano
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.

About the Role

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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

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Division

Operations

Business Unit

Production / Manufacturing

Location

Italy

Site

Torre Annunziata

Company / Legal Entity

IT08 (FCRS = IT008) Novartis Farma S.p.A.

Functional Area

Technical Operations

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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