Temporaire

You are a supply chain SAP expert and you are looking for a new challenge ? We have your new opportunity. For one of our client based in Neuchâtel we are looking for a Quality Control Analyst – Microbiology

 

Vos tâches

Duties and Responsibilities
a. Microbiological testing of raw materials and drug products according to incoming testing, release and stability specifications;
b. Environmental monitoring of cleanrooms (microbiological and particles tests), compressed air, and waters (microbiological tests, TOC, conductivity, nitrates);
c. Microbiological validation activities (writing of protocols, execution of validation, writing of reports);
d. Review of analytical raw data generated in the Microbiology Laboratory;
e. Supply management of consumables, including purchase requisitions;
f. Release of culture Media (growth promotion testing) and material used in Microbiology laboratory;
g. Identifications of microorganisms;
h. Execution and review of simple analyses such as packaging components testing, AQL, visual inspection of pharmaceutical products, etc.;
i. Support to maintenance/calibration of equipment and keeps relationship with suppliers;
j. Training of other members of Quality Control or other departments;
k. General laboratory tasks (sample management, waste disposal management, cleanings, etc.);
l. Creation and update of procedures, work instructions and other QC documents
m. Participation and presentations at team meetings
n. Participation in projects and implementation of continuous improvement actions in the laboratory
o. Other responsibility assigned by the laboratory management.

 

Votre profil

Competences
The QC Analyst – Microbiology is part of the Microbiology team of the Quality Control department at Celgene International Boudry. The scope of this team includes responsibility for microbiological testing of raw materials and drug products, Environmental Monitoring, and acting as Microbiology SME for different Celgene sites and partners.
The main responsibilities of the position include performing and reviewing microbiological tests on raw materials, manufactured drug products and stability samples; performing Environmental Monitoring in cleanrooms, waters and compressed gases, and supporting other QC groups with various activities, such as packaging components testing, visual inspection of pharmaceutical product, sample management, etc. The QC analyst may also participate in projects related to laboratory safety or continuous improvement.
The QC Analyst – Microbiology Activities carries out her/his activities in compliance, at all times, with laboratory procedures and safety rules (EHS) as well as good documentation and good manufacturing practices (GDP and GMP).

2. Skills/Knowledge Required
• Good knowledge of microbiology testing according to compendial harmonized methods;
• Good knowledge of environmental and water monitoring;
• Good knowledge of good microbiological practices and contamination control concepts;
• Knowledge of microbiological method validation according to compendial harmonized methods;
• Good knowledge of laboratory safety rules;
• Good knowledge of the general organization of a quality control laboratory;
• Good knowledge and ability to apply GDP and GMP rules;
• General computer literacy (Windows and MS Office) and ability to use a LIMS;
• Fluency in French and professional command of English (oral and written) – (B1 Min);
• Good collaboration and communication with QC members and other departments;
• Able to work autonomously and collaboratively within a team;
• Basics of the « LEAN » philosophy and 5S concept;
• Pragmatic, structured, with good organizational skills;
• Flexible, able to adapt to change
3. Duties

 

Date d'entrée

À convenir


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