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Novartis

Global pharmaceutical company delivering science-based innovations

Associate Expert Drug Supply

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeIvrea, Italy

About the Job

Requirements

  • A technical or scientific high school background is mandatory.
  • A minimum of two years of experience in GMP manufacturing support or a technical role is required.
  • Previous experience in sterile injectable pharmaceutical companies is required.
  • Proficiency in Italian is required.
  • Good scientific and technical understanding is required.
  • The candidate should be able to understand production processes or learn them quickly.
  • Quality and compliance skills and a good understanding of regulatory requirements across multiple health authorities are required.
  • Good working knowledge or understanding of typical manufacturing IT systems, such as SCADA and HMI, is required.
  • Good knowledge of office software applications is required.

Responsibilities

  • Carry out the production of radiopharmaceuticals according to GMP rules and approved standard operating procedures.
  • Work shifts and perform activities for the preparation, production, and packaging for shipping of sterile radioactive drugs.
  • Execute assigned activities in compliance with internal procedures, including health, safety and environment requirements and EU GMP Annex 1 and Annex 3, and comply with applicable laws and regulations.
  • Perform routine setup and cleaning, microbiological verification of pharmaceutical areas and equipment, and periodic cleaning activities in areas of the plant as required by GMP.
  • Prepare all raw materials needed for production, including batch-related kit preparation.
  • In accordance with the Production Supervisor, manage material stocks and waste materials.
  • Follow good documentation practices when printing, filling, and signing documents in accordance with ALCOA+.
  • Promptly report deviations and out-of-specification findings detected during production to the Production Supervisor and the Qualified Person and/or Health, Safety and Environment Manager.
  • Perform logistics activities, including transportation and related documentation for incoming materials, replenishing stock areas, and shipping packaging materials.
  • Perform radioactive-waste management activities, including transportation and related documentation.
  • Support external specialized personnel carrying out ordinary and extraordinary maintenance and qualification activities.
  • Collaborate with the Production Supervisor to train new personnel.
  • Support the site quality system by providing production-area input and sustaining continuous facility improvement.
  • Observe safety requirements, including D.Lgs. 81/08, D.Lgs. 101/95, and Global and local Health, Safety and Environment standard operating procedures, as well as GMP regulations and housekeeping practices.
  • Provide continuous feedback and act as a point of contact for improvements and changes to optimize production-process quality and efficiency.
  • Perform technical tests and support process and product qualification and validation phases.

Desired Qualifications

  • A university degree in Science is desirable, including Pharmacy, Chemical Engineering, or Pharmaceutical Technology, or equivalent job experience.
  • Radiopharmaceutical experience is desirable.
  • English is desirable.
  • Competencies in change management, adaptability, and working under pressure are desirable.
  • Skills or knowledge in Environment Health and Safety, Environment Management, Laboratory Instrumentation, Manufacturing Processes, Materials Science, Process Simulation, and Standard Operating Procedures are listed as desired.

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1970

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