Roche
Biologics
Specialist,LS&ASAT,Biologics
“Specialist, LS & ASAT, Biologics at Roche. Skills: Equipment qualification, System validation, Sample management, Testing material management. Perform qualification, validation, calibration, maintenance. Set up master data”
What You'll Achieve.
Ensure on-going compliance; Meet the intended standard and regulation requirements; Ensure data integrity; Maintain the global level of GMP compliance; Ensure they are in good order to meet the analytical needs any time; Ensure on time delivery for QC digital system
Industry & Context.
Problem investigation; Investigate and solve the problem in correct way and in time
What They're Looking For.
Must Have
2 or more years of QC experience, Fluent communications skills in English
Nice to Have
Life Sciences, Microbiology, or Analytical Sciences degree, MNC Bio-pharma experience, QC new system startup readiness and operation ramp up experience, Project management skills
What You'll Do.
Perform qualification
Adhere to SOPs and safety requirements
Document laboratory work
Assist Head of Lab Support
Complete GMP Self-Inspection
Present technical analytical data
Manage sample and testing materials
Report abnormal status and deviations
Identify abnormal status and unexpected results
Support supervisors to investigate problems
Maintain laboratory cleanliness
Maintain inventory of bioanalytical materials
Support lean initiatives
Execute equipment qualification and validation
Execute material inventory management
Support digital system deployment
How You'll Work.
Team & Collaboration
Liaises across the design, construction, qualification of the QC area; Work independently and with a level of autonomy; Assist Head of Lab Support
Communication Scope
Fluent communications skills in English; Presents technical analytical data clearly and concisely
Process & Methodology
Greenfield project management, Operation readiness, Start-up phase, Project management skills
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