Quality Control Analyst Microbiology

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

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 degreeis 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. How can we achieve this? 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)