QC Reviewer - FSP, client dedicated
QC Reviewer - FSP, client dedicated
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Thermo Fishers clinical research business is a leading global contract research organization and world leader in serving science. We are passionate deliberate and driven by our mission to enable our clients to make the world healthier safer and cleaner.
Within our Analytical Services team we have a functional service provider solution which is an outstanding partnership that allows our customers to use the experience of our staff while allowing you the employee to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company all while maintaining full-time benefits.
The role of QC Reviewer will ideally be based fully or partially at our clients site in Stevenage however remote working may be considered.
As a QC Reviewer within our client dedicated team you will provide data management in support of key workflows which includes data checking and CMC Statistics data management
Responsibilities:
Verify data in the BYOD data product matches data in source systems
Verify data in source documents matches data matches raw data
Identify gaps where data inconsistencies are identified
Manage the data associated with CMC statistics workflows
Provide consolidated tables generated from multiple data sources
Communicate any discrepancies with the parties involved and take steps to correct them in a timely manner.
Performing a check of the current data to ensure that it is accurate consistent and reflects its intended purpose.
Assesses procedures for accuracy simplicity and practicality and influences changes as appropriate
Builds and maintains good working relationships with internal and external partners
Manages issues and risks identified in area of responsibility
The successful candidate will have
BSc/MSc in a Scientific Discipline
Previous experience in a pharmaceutical manufacturing environment
Previous experience in a comparable role including prior experience with data review data verification and data management
Knowledge of GMP/GxP regulations
Strong attention to detail with a focus on quality
Fluency in Enlgish with strong communication skills (oral and written)
Proactive attitude with willingness to learn and adapt to meet business needs
Our 4i Values:
Integrity Innovation Intensity Involvement
If you resonate with our 4i values above and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the worlds most urgent health needs submit your application wed love to hear from you!
Employment Type
Full-Time
