Associate Expert Drug Supply

IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl; Ivrea; On-site; EUR 30,000 - 56,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

Minimum 14 weeks paid parental leave

Job summary

Novartis in Ivrea, Italy, is seeking a production specialist to carry out radiopharmaceutical production in accordance with GMP rules and approved SOPs. The role involves shift work and internal rotation planning, with responsibilities spanning preparation, production, packaging, and shipping of sterile radioactive drugs.

Qualifications include a technical/high school background (university science degree desirable). English is desirable; Italian is the local language.

Qualifications

• High School technical background mandatory
• Science degree desirable (Pharmacy/Chemical Engineering)

Responsibilities

• Perform preparation, production and packaging for shipping of sterile radiopharmaceuticals
• Ensure compliance with GMP, EU regulations and internal SOPs
• Conduct routine setup, cleaning and microbiological verification of production areas and equipment
• Prepare raw materials and manage stock for production
• Follow ALCOA+ in printing, filling and signing documents
• Report deviations to Production Supervisor and Qualified Person/HSE Manager
• Handle logistics for incoming materials and packaging for shipping
• Assist maintenance/qualification activities as needed
• Support training of new personnel and continuous improvement of the facility
• Observe safety requirements and GMP regulations during duties
• Provide input for quality improvements and process validation

Skills

GMP manufacturing

Radiopharmaceutical production

SCADA/HMI systems

ALCOA+ documentation

Quality compliance

Education

High School technical background

Science degree desirable

Tools

SCADA

HMI

Job description

Salary Range: €30,200.00 - €56,000.00 Job Description Summary Carry out the production of radiopharmaceuticals according to GMP rules and approved SOPs. The role foresees working in shifts including morning and afternoon work according to an internal rotation plan.

#LI-Onsite Location: Ivrea, Italy Relocation Support: This role is based in Ivera, Italy. Novartis is unable to offer relocation support: please only apply if accessible.

Major accountabilities

• Work in shifts, is responsible to perform the necessary activities for the preparation, production and packaging for shipping of sterile radioactive drugs
• Execute all assigned activities in compliance with internal procedures (HSE, EU GMP Annex 1 / Annex 3, others) and in compliance with applicable laws and regulations
• Perform routine setup and cleaning, microbiological verification of pharmaceutical areasand equipmentand all areas of the Plant with a need for periodic cleaning activities based on GMP
• Perform the preparation of all raw materials needed for the production (batch related kit preparation)
• According with the Production Supervisor, perform the management of material stocks and waste materials
• Follow the GDP in printing, filling and signing all documents (ALCOA+)
• Promptly report to the Production Supervisor and the Qualified Person and/or the HSE Manager any deviation and/ or out of specification detected during the production process
• Perform logistics activities (transportation and documentation related) about the incoming of materials, refilling of the stock areas and packaging materials for shipping.
• Perform activities related to waste management (transportation and documentation related) for radioactive waste
• Support external specialized personnel in carrying out ordinary and extraordinary maintenance/qualificationactivities
• Collaborate with the Production Supervisor to the training of new personnel
• Support the site quality system by providing input from the production area and sustaining the continuous improvement of the facility
• Observe all safety requirements (D.Lgs. 81/08; D.lgs 101/95, Global and local HSE SOPs), GMP regulations (AIFA, FDA), and housekeeping practices while performing duties.
• Provides continuous feedback and is the point of contact for generating improvements and changes aimed at optimizing the quality and efficiency of production processes.
• Responsible for performing technical tests and supporting the qualification and validation phases of processes and products.

Education & Qualifications

• Technical/Scientific background/education (High School) is mandatory
• University degree in Science is desirable, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent job experience.

Languages

• English: desirable
• Italian (Local Language): proficient

Experiences

• Minimum 2 years experience in GMP manufacturing support / technical role
• Previous experience in sterile injectable pharmaceutical companies (radiopharmaceutical experience is desirable)

Competencies

• Good scientific and technical understanding
• Team player with strong team spirit
• Change management, adaptability, ability to work under pressure
• Good understanding or capacity to quickly understand production processes
• Quality and compliance skills
• Good understanding of regulatory requirements across multiple health authorities

Technical / Functional Skills & Knowledge

• Good working knowledge/understanding of typical manufacturing IT system (SCADA, HMI etc)
• Good office software applications

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

• insurance plans
• retirement plans
• wellbeing resources
• global recognition programs
• flexible and hybrid working options, where possible
• minimum 14 weeks paid parental leave

Expected Annual Base Salary Range for role: €30,200 to €56,000

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Commitment to Diversity and Inclusion / EEO paragraph Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Skills Desired Environment Health and Safety, Environment Management, Laboratory Instrumentation, Manufacturing Processes, Materials Science, Process Simulation, Standard Operating Procedure (SOP)