Quality on the Floor Specialist

at  Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is searching for a highly motivated individual with strong work behaviors to join our team as a Quality on the Floor Specialist. This role provides the chance to work in a world-class organization and contribute to the impeccable execution of our production processes.
As a Quality on the Floor Specialist, you will have the opportunity to manage two key areas of work. Firstly, you will be responsible for the review of GMP batches, including release and characterization, registration, and stability. Additionally, you will play a crucial role in the qualitative management of production activities.

Your responsibilities will include:

• Overseeing and managing activities in the Production Department, making critical decisions during the production of commercial batches, process validation batches, and Media Fill batches.
• Conducting periodic quality surveillance of production activities and proactively promoting a culture of quality throughout the departments.
• Performing preliminary investigations of deviation events and collaborating with the Quality Operations function and Department Quality Specialists to identify appropriate corrective or preventive actions.
• Approving GMP parameters for production, including equipment, software, machine recipes, and serialization product data.
• Conducting GMP-related activities to improve, control, evaluate, and correct production processes.
• Performing batch record reviews for relevant GMP batches, ensuring compliance with specifications, company procedures, and regulations.
• Analyzing customer feedback on commercial batch documentation and preparing responses.
• Assisting with continuous improvement initiatives, training and procedure development, and the distribution of Master Batch Records.

To be successful in this role, you will need:

• A degree in CTF, Pharmacy, Chemistry, Biology, or a related scientific field, or equivalent experience in these areas.
• Technical expertise in production and quality control/assurance of pharmaceutical products.
• Familiarity with GMP/FDA regulations and Annex 1.
• Proficiency in key company software systems (TrackWise, Documentum, SuccessFactors) and Microsoft Office tools.
• Previous experience in pharmaceutical production and aseptic control (preferred).
• Strong communication skills in Italian (native) and English.

If you are an ambitious and proven professional looking for a challenging role in quality management, this position is for you. Join Thermo Fisher Scientific Inc. in Monza, Province of Monza and Brianza, Italy, and be part of our exceptional team driving excellence in the pharmaceutical industry.
Thermo Fisher Scientific Inc. is an equal opportunity employer and encourages applications from candidates of all backgrounds.
Apply now and take the next step in your career with Thermo Fisher Scientific Inc.

Your responsibilities will include:

• Overseeing and managing activities in the Production Department, making critical decisions during the production of commercial batches, process validation batches, and Media Fill batches.
• Conducting periodic quality surveillance of production activities and proactively promoting a culture of quality throughout the departments.
• Performing preliminary investigations of deviation events and collaborating with the Quality Operations function and Department Quality Specialists to identify appropriate corrective or preventive actions.
• Approving GMP parameters for production, including equipment, software, machine recipes, and serialization product data.
• Conducting GMP-related activities to improve, control, evaluate, and correct production processes.
• Performing batch record reviews for relevant GMP batches, ensuring compliance with specifications, company procedures, and regulations.
• Analyzing customer feedback on commercial batch documentation and preparing responses.
• Assisting with continuous improvement initiatives, training and procedure development, and the distribution of Master Batch Records

To be successful in this role, you will need:

• A degree in CTF, Pharmacy, Chemistry, Biology, or a related scientific field, or equivalent experience in these areas.
• Technical expertise in production and quality control/assurance of pharmaceutical products.
• Familiarity with GMP/FDA regulations and Annex 1.
• Proficiency in key company software systems (TrackWise, Documentum, SuccessFactors) and Microsoft Office tools.
• Previous experience in pharmaceutical production and aseptic control (preferred).
• Strong communication skills in Italian (native) and English