Pharmaceutical Development Specialist

4 settimane fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

Work Schedule Standard (Mon-Fri)

As a member of the Thermo Fisher Scientific team, you will contribute to the development of life-saving and innovative drugs. You will work in a dynamic and exciting environment, where a strong GMP background and effective communication skills are key.

Responsibilities:

  • Work closely with cross-functional teams for the process design stage of new products.
  • Review all validation documents to assure the production of high-quality pharmaceutical products that meet strict regulatory requirements.
  • Participate in the investigation related to validation activities, supporting in the impact assessment evaluation and in the implementation of corrective and preventive actions.
  • Support the regulatory team during the submission phase of new commercial products.
  • Review change control related to registration and PPQ batches.
  • Provide quality support for new product transfer and implementation of new processes.
  • Find opportunities for process improvements and lead initiatives to improve the validation process.
  • Assure that accurate cross contamination control strategies are in place to avoid contamination and mix up event.

Requirements:
  • We are looking for an ambitious individual with a degree in Medicinal Chemistry and Pharmaceutical Technologies/Pharmacy/Chemistry/Chemical Engineering/Biotechnology or related scientific subject areas.
  • Experience in development and manufacturing of sterile products and, if possible, with experience in process and cleaning validation topics.
  • Strong knowledge of regulatory requirements and industry standards.
  • Proficient English with advanced written and oral communication skills.
  • Proficiency in Microsoft Office software; knowledge of statistical tool and Trackwise software is a plus.
  • Good problem-solving abilities, excellent communication and team working skills; ability to multi-task and prioritize to meet important goals.
  • Critical spirit and Attention to details.

What We Offer:
  • A collaborative and inclusive work environment.
  • The opportunity to work with brand-new technology and contribute to impactful projects.
  • Join us in Monza and be part of a company that is determined to make a difference.
  • Your work will help ensure we continue to deliver innovative solutions that improve the lives of people around the world.


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