Pharmaceutical Development Specialist
4 settimane fa
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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