Apply: Quality Control (QC) Lead

• 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