Manufacturing Specialist Biotechnology
volt
Singapore
2d ago

Responsibilities

  • Ensure timely, accurate and quality production under ISO 13845 and other relevant regulatory requirements
  • Aid in routine update and maintain of both manufacturing inventory during material transfer.
  • Support production, R & D prototyping activities and process validation activities
  • Draft SOPs and work instruction with the support of QA department
  • Perform calibration and maintenance of all equipment in the laboratory to ensure proper working conditions
  • Perform regular environmental monitoring and sanitization of facilities
  • Participate in the development of new manufacturing and quality control processes.
  • Support manufacturing investigations, change control and root cause investigations for non-conformance.
  • Requirements

  • Degree / Diploma in Biotechnology, Life Sciences, Chemical Engineering or equivalent least
  • Experience in a medical device / biotechnology manufacturing setup with good knowledge of current GMP standards
  • Good knowledge in operating or set up ERP systems such as Sage, SAP or Netsuite
  • Experience with activities such as buffer formulation, dispensing and kitting will be a plus
  • Prior experience with manufacturing / QA or equivalent
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