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Pharmaceutical Process Specialist
2 mesi fa
Job Title: Pharmaceutical Process Specialist
As a key member of the Thermo Fisher Scientific team, you will be responsible for designing, validating, and ensuring the regulatory approval of life-saving and innovative drugs. Your contributions will make a significant difference in the quality of our pharmaceutical products.
Responsibilities:
• Work closely with cross-functional teams for the process design stage of new products.
• Participate in the definition of process/cleaning validation strategy and review validation documents to ensure the production of high-quality pharmaceutical products that meet strict regulatory requirements.
• Support the regulatory team during the submission phase of new commercial products and review change control related to registration and PPQ batches.
• Provide quality support for new product transfer and implementation of new processes, and find opportunities for process improvements and lead initiatives to improve the validation process.
Requirements:
• A degree in Medicinal Chemistry and Pharmaceutical Technologies, Pharmacy, Chemistry, Chemical Engineering, or Biotechnology, or related scientific subject areas.
• Experience in development and manufacturing of sterile products and process and cleaning validation topics.
• Strong knowledge of regulatory requirements and industry standards.
• Proficient English with advanced written and oral communication skills, and proficiency in Microsoft Office software, and knowledge of statistical tools and Trackwise software is a plus.
• Good problem-solving abilities, excellent communication and team working skills, and ability to multi-task and prioritize to meet important goals.
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.
