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Job Details

Location
Singapore
Salary
Competitive package
Job Type
Permanent
Ref
BH-157317
Contact
Joanne Koo
Contact email
Email Joanne
Contact phone
65 6692 0751
Posted
2 months ago
  • Start-up environment
  • Reports to Assistant General Manager
  • Based in Singapore
 
Headquartered in Singapore, our client is a leading biotechnology company with sales globally, developing cutting-edge miRNA assay technologies and products for research and clinical diagnostic use. They partner with world-renown clinical institutions and multinational pharmaceutical companies to develop novel blood-based cancer diagnostic and prognostic tests.
 

JOB RESPONSIBILITIES
  • Set up and perform Quality Control procedures across a few product lines
    • Diagnostics
    • Life Science
    • Reagent support for manufacturing site
  • Lead the QC team in ensuring that QC tests are performed in a scheduled and timely manner
  • Accountability for all passes and failures of QC tests within the Quality Management System
  • Establish Quality Work instructions (QWI) and SOPs along with proper reporting and establishment of acceptance criteria
  • Perform Technology Transfer of QC techniques from R&D across product lines from time to time
  • Work with Logistics, Quality Assurance and Manufacturing Functions for the timely release of products and intermediates
  • Maintain the Quality Control Laboratory in good operational condition according to ISO 13485, CE IVD and GMP standards
  • Set KPIs and goals for the QC department
  • Looks into methods to improve Quality Control procedures by looking at various methods (miRNA Isolation->Reverse Transcription -> qPCR workflow, ELISA, RNAse/DNase test, analysis of HPLC reports
  • Training of staff to handle Quality Control procedures and ensure consistent adherence to methodology
  • In the event of a failure in QC, the Lead Is expected to troubleshoot the failure efficiently and turn around quickly, while maintaining a good set of Records and Based on the Non Conformance system of the company
  • Setup and execute Real time Stability studies and periodic reporting on all intermediates and Finished goods

REQUIREMENTS
  • Minimum 3 years in the field of Quality Control in a biotechnology company
  • A Degree/Diploma in Biotechnology, Biomedical Science, Chemistry or equivalent
  • Previously worked in a GMP / ISO 13485 certified company as an experienced Quality Control Personnel
  • Ability to write Quality Control procedures and has experience in validating these procedures.
  • Demonstrate ability to communicate, present and influence credibly and effectively at all levels of the organisation especially during function meetings
  • Has good working knowledge on molecular and chemical QC techniques such as qPCR, ELISA, HPLC, Nuclease testing
  • Able to keep neat and organized record and files.
 
 
Reg No. R1109555
EBC Connect Pte Ltd
Licence no. 17C8975