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System Lifecycle Support Interview - Coggle Diagram
System Lifecycle Support Interview
SPOC
Who? :question:
manager
Reco: Divine Mon :check:
-Maint/Calib
Supervisor
Reco: Melissa Chong
Reco: Dhruv Shah
Reco: Sabrina Ng
MSAT: Mindy/Alan
LinkedIn
19 Y exp @ gene.
NPI/Multi product/DS/DP
Stages of production process: cell banking, media preparation, fermentation, harvesting, and purification and IQ/OQ/PQ requirements
SLS team
Dhruv Shah
GSP36
:green_cross:
Campaigns "cleaning?/Clinical"
Wide range of equipment.
Autoclaves
7 M, 2 F
Oscar
Requalification Test Plan Drug Product Autoclaves :green_cross:
Rohan
Proficient in experimental design and statistical data analysis to drive process optimization :green_cross:
Statistical Process Control :green_cross:
Rachael Lin?
LinkedIn
GMP
Change Control
Root Cause Analysis
21 CFR 11
Topics
Format
Phone :green_cross: Cal/Email
Course
JD :question:
Val Eng 1
ASTM E2500
:check:
Passionate in assisting manufacturing capability and ensuring manufacturing systems are fit for intended use
Interested to learn established engineering methods/standards applied throughout the life cycle to deliver appropriate and effective solutions.
ASTM DOC:
Dev Op.
Resume/CL :green_cross:
Initial system qualification/re-qualification
modeling data using statistical analysis
VAL-0129471 Lyophilizer
VAL-0131408 Autoclave
GSP036
Relevant Exp.
BME
Thermo/Eng
SAL Bioengineering Fund
Gene
FTIR PC
Trainings
gSTART
cGMP
21 CFR 11
21 CFR 210 & 211
Questions
Behavioral Q's
Technical
Consultancies interview