Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Are you looking to make a significant impact in the pharmaceutical manufacturing industry? Join Thermo Fisher Scientific Inc. in Monza as a Production Support Expert and be part of an exceptionally driven team dedicated to advancing world-class pharmaceutical production!

Purpose of the position/responsibilities:

Maintain pharmaceutical sterile injectables production compliance with US and EU GMP and company quality standards through prevention and intervention suggestions.

Specific tasks/primary activities:

Control

Mantain continuous surveillance of the production lines for sterile forms (cleaning, blending, functionality, defects) to ensure adherence to current regulations and company quality benchmarks.

Quality

Engage in outlining and orchestrating testing and validation procedures for machinery, ensuring alignment with current regulations and company quality criteria.

Participate in self-audits and implement corrective actions to maintain regulatory compliance.

Analyze and determine necessary actions to remove the causes of defects and complaints.

Propose and participate in GMP training courses applicable to production activities based on control findings.

Procedures

Contribute to the issuance and revision of procedures and work sheets, ensuring their application during operational phases.

Requirements and qualifications:

(A) ESSENTIAL:

Studies/Diplomas/Training courses:

• Diploma with proven experience or degree

Technical and IT knowledge:

• Knowledge of machinery, plants, and methodologies for drug production
• In-depth knowledge of GMP regulations
• Knowledge of issues related to aseptic production
• Ability to use main information systems

Professional experiences:

• Solid experience in QA/Production in pharmaceutical companies

Languages:

Italian

English

Personality traits:

• Organizational skills
• Observation skills
• Relational and problem solving
• Critical spirit

(b) desirable:

Previous involvement in manufacturing sterile and oral injectable medications

Join us and help ensure flawless production processes while working collaboratively in an ambitious environment. Your expertise will be key to our success!