Quality Control Analyst Microbiology

IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl; Saluggia; In loco; EUR 27.000 - 49.000; Tempo pieno

Descrizione del lavoro

Novartis in Italy is seeking a Microbiology QC professional to execute and document testing in GMP-compliant labs. You will organize and oversee laboratory operations and ensure alignment with regulatory SOPs across the department.

The role requires 2+ years in Microbiology QC within pharma, fluency in Italian, and good English. Radiopharmaceutical experience is a plus, with opportunities to contribute to technology transfer and quality systems.

Competenze

• 2+ years experience in Microbiology QC in Pharmaceutical industry
• Experience in radiopharmaceuticals is a plus
• Fluent Italian, good knowledge of English

Mansioni

• Perform analysis on excipients, drug substances, drug products, water and primary packaging according to internal SOPs
• Execute stability study protocols, process validation protocol, method validation protocols and every study tied to drug products involved in technology transfer for the field of expertise
• Perform the sterility test on the products from AAA site
• Perform instrument performance qualification tests whenever required
• Register the analysis correctly and in compliance with ALCOA+ principles other than the relevant applicable SOPs
• Collaborate with management for reaching the department objectives
• Know and apply the relevant SOPs for the field of expertise
• Collaborate in the maintenance of good conditions of laboratories, instruments and work environment
• Collaborate in keeping quality control SOPs updated
• Coordinate microbiological laboratory activities

Conoscenze

Chemistry Laboratories

Collaboration

Communication

Data Integrity

Deadline Management

Decision Making

GMP

QA

Quality Compliance

Quality Control

QMS

SPC

Formazione

Biological or Chemical degree

Descrizione del lavoro

Salary Range: 26.500,00 € - 49.300,00 €

Job Description Summary

Execution and documentation of microbiological testing in conformity to GMP standards and SOPs in force efficiently, competently and in the planned terms. Compliance with the existing regulation on ecology and security. Organization and control of the laboratory and analytical equipment in the field of expertise

Job Description

• Perform analysis on excipients, drug substances, drug products, water and primary packaging according to internal SOPs
• Execute stability study protocols, process validation protocol, method validation protocols and every study tied to drug products involved in technology transfer for the field of expertise.
• Perform the sterility test on the products from AAA site
• Perform instrument performance qualification tests whenever required
• Register the analysis correctly and in compliance with ALCOA+ principles other than the relevant applicable SOPs
• Collaborate with management for reaching the department objectives
• Know and apply the relevant SOPs for the field of expertise
• Collaborate in the maintenance of good conditions of laboratories, instruments and work environment
• Collaborate in keeping quality control SOPs updated
• Coordinate microbiological laboratory activities

Essential requirements

• Education: Biological or Chemical degree is desirable.
• 2+ years experience in Microbiology QC in Pharmaceutical companies; experience in radiopharmaceutical companies will be considered a plus.
• Fluent Italian, good knowledge of English.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

Benefits and rewards:

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:

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

Skills Desired

• Chemistry Laboratories
• Collaboration
• Communication
• Data Integrity
• Deadline Management
• Decision Making
• Good Manufacturing Practices (GMP)
• Quality Assurance (QA)
• Quality Compliance
• Quality Control (QC)
• Quality Management Systems (QMS)
• Statistical Process Control (SPC)

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .