Quality Control Analyst Microbiology

Novartis Italia; Saluggia; On-site; EUR 42,000 - 55,000; Full time

Job summary

Novartis Italia in Saluggia, Piedmont, seeks a Microbiology QC Specialist to perform analyses on excipients, drug substances, water and primary packaging in compliance with GMP and internal SOPs.

Responsibilities include validating stability, process and method protocols, conducting sterility tests, coordinating microbiological activities and ensuring data integrity per ALCOA+ guidelines. Fluent Italian and English are required.

Qualifications

• 2+ years in Microbiology QC in pharma.
• Experience in radiopharmaceuticals a plus.
• Fluent Italian and good English.

Responsibilities

• Perform analysis on excipients, drug substances, drug products, water and primary packaging according to internal SOPs
• Execute stability and method validation protocols and studies tied to drug products used in technology transfer
• Perform sterility tests and coordinate microbiology activities
• Register analyses in ALCOA+ compliant records and SOPs
• Collaborate to achieve department objectives and maintain lab conditions

Skills

Microbiology QC

Fluent Italian

English knowledge

Education

Biological degree

Chemical degree

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

About The Role

Major Accountabilities

• 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.

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? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we'll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)