Microbiology QC Analyst - GMP Pharma Quality

Novartis; Saluggia; On-site; EUR 27,000 - 49,000; Full time

Job summary

Novartis in Italy is seeking a Microbiology QC specialist to execute analyses on excipients, drug substances, drug products, water and primary packaging according to internal SOPs and GMP standards, and to organize and control the laboratory and equipment in the field of expertise.

The role requires a Biological or Chemical degree and at least 2 years of microbiology QC experience in pharmaceutical companies; fluent Italian with good English.

Qualifications

• 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.

Responsibilities

• 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

Skills

GMP

Quality Assurance

Quality Control

QA

QMS

SPC

Data Integrity

Chemistry Laboratories

Collaboration

Communication

Deadline Management

Decision Making

CQA

Education

Biological or Chemical degree

Job description

Novartis in Italy is seeking a Microbiology QC specialist to execute analyses on excipients, drug substances, drug products, water and primary packaging according to internal SOPs and GMP standards, and to organize and control the laboratory and equipment in the field of expertise.

The role requires a Biological or Chemical degree and at least 2 years of microbiology QC experience in pharmaceutical companies; fluent Italian with good English.