Quality Assurance Specialist

4 settimane fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

This is an exciting opportunity to contribute to the success of Thermo Fisher Scientific Inc. as a Quality Specialist in our PDS Business unit.

As a Quality Specialist, you will play a vital role in ensuring compliance with current US GMP, EU GMP regulations, and our company's outstanding quality standards.

Key Responsibilities:

  • Monitor sterile production lines to ensure compliance with our company's quality standards.
  • Implement control measures to maintain outstanding quality throughout production activities.

Quality Focus:

  • Participate in defining and coordinating testing and validation activities for machinery.
  • Collaborate with team members to settle quality standards and incorporate them into the production process.
  • Actively participate in audits and implement corrective actions to improve processes.
  • Analyze and resolve problems to ensure our products meet the highest quality standards.
  • Propose GMP training courses based on supervising and control results.

Procedure and Collaboration:

  • Collaborate with cross-functional teams in developing and revising procedures and work instructions.

Rapports:

Internal:

  • Develop a culture of collaboration and partnership with QA/QC, Scientists, Warehouse, and Engineering.

External:

  • Maintain positive relationships with machinery and equipment suppliers.
  • Collaborate with external partners to implement effective processes.

Qualifications:

The preferred candidate has a strong experience in the pharmaceutical environment, shows a scientific background, and knowledge of machinery, equipment, and methodologies for pharmaceutical production, GMP regulations included.

Familiarity with aseptic production challenges is a major plus.

Confirmed experience in QA/Production in pharmaceutical companies is important, demonstrating the ability to efficiently implement quality control measures.

Language:

Italian and English

Personality Traits:

  • Highly organized: Your exceptional communication skills will enable you to handle multiple tasks and ensure the smooth flow of our production operations.
  • Strong observation skills: Your keen eye for detail will allow you to promptly identify any deviations or issues and address them efficiently.
  • Excellent communication skills: Your ability to build positive relationships and effectively connect with colleagues at all levels will contribute to a collaborative work environment.

Thermo Fisher is able to offer interesting benefits, an important career path, and learning opportunities.

Contribute to the success of our team and play a relevant role in ensuring the detailed production of pharmaceuticals.

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