Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an outstanding combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
What will you do?
Thermo Fisher mRNA unit in Monza is looking for a Change Control and GMP documentation specialist!
Assist the mRNA QA Manager with change management, coordinating activities, closing changes in Global TrackWise System, reviewing SOPs and quality documents, and conducting training and inspections.
Technical documentation analysis:
- Review technical documentation for proposed changes to gather info, follow procedures, identify risks, and evaluate mitigation.
- Review Company procedures and other quality-related documentation in agreement with the cGMP and Corporate documents.
Control of change control:
- Lead change control process relating to raw materials, processes, plants, products in compliance with agreed timelines and company procedures.
- Gather change requests from other departments, evaluate their effect on GMP status, and review implementation plans and closing reports.
- Interact with all internal functions in order to perform a complete change control assessment.
- Interact with customers for change control topics (change control review, monitoring and implementation).
- Improvement of Change control management process.
Technical Skills:
- Degree in CTF, Pharmacy, Chemistry, Biology, or related scientific field, or equivalent experience in the same domains.
- Experience in Quality Assurance Department of Pharma/API industry: change control, deviations, recalls and OOS, OOT investigations, CAPA management.
- Experience with clients and suppliers’ management is a plus.
- Experience in Microsoft Office and Excel.
- Familiarity with GMP/FDA regulations.
Soft Skills:
- Strong teamwork, organizational, and social skills.
- Critical approach, details oriented.
- Able to identify the priorities and to coordinate the activities independently.
For more information, please visit www.thermofisher.com
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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