Change control and GMP documentation specialist
Change control and GMP documentation specialist
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob 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 lifechanging therapies we are here to support them. Our distributed team delivers an outstanding combination of innovative technologies purchasing convenience and pharmaceutical services through our industryleading 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 qualityrelated 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
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.
Required Experience:
Director
Employment Type
Full-Time
