GMP Microbiology QC Analyst — Drug Product

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

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.