Pharmaceutical Development Specialist
6 ore fa
About Us
At Thermo Fisher Scientific, we're a global leader in serving science. With our extensive portfolio of products and services, we enable customers to make the world healthier, cleaner and safer.
Our Team
We value performance, quality, and innovation. Our team is encouraged to perform at their best, with access to resources and opportunities to create significant contributions.
The Role
We're seeking a skilled Pharmaceutical Development Specialist to join our PDS Analytical Development & GMP Department. As a key member of our team, you'll be responsible for assigned projects, ensuring successful project continuation within the department.
Responsibilities
- Responsible for analytical documentation of APIs, excipients, and DP (release and stability tests)
- Collaborate with clients, QC PDS, regulatory department, QC compliance, QA, and QO to issue correct documents for PDS projects, adhering to ICH and pharmacopoeia guidelines
- Provide compliance consulting and strategic advice to internal and external clients on compliant documentation for their products
- Develop project-specific strategies, technical expertise in QC documentation matters, and coordinate oversight for key client projects
- Serve as executive contact for key clients, attending regulatory authority meetings and public relation functions, ensuring quality performance for managed projects
- Evaluate OOS, OOT, and laboratory investigations in terms of recurrences, root cause, trend, and define CAPAs
- Perform laboratory investigations, OOS, and OOT, and any deviations and CAPA related to them, collaborating with supervisor and team leader
Requirements
To succeed in this role, you'll need:
- Bachelor's degree in chemical engineering, chemistry, or equivalent work experience with pharmaceutical companies
- GMP standards applied to Quality Control laboratories, particularly referring to stability studies, laboratory data management, and SOP writing
- English and Italian language proficiency
- Flexibility, adaptability, good organization, and planning skills
- Excellent listening, oral, and written communication skills
- Ability to work in a team
Estimated Salary Range: $90,000 - $120,000 per year, depending on qualifications and location. We offer a comprehensive benefits package, including health insurance, retirement plans, and paid time off.
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