QC Systems Specialist

17 hours ago


Singapore ORKA CONSULTING PARTNERS PTE. LTD. Full time $60,000 - $120,000 per year
Key Responsibilities:
  • Install, configure and troubleshoot IT / OT system (e.g., firewall, antivirus, backup, archive, ) supporting pharmaceutical QC laboratory equipment.
  • Install, configure and troubleshoot Windows OS migration for GMP computerised system.
  • Configure laboratory equipment integration solution.
  • Troubleshoot any connectivity, data transfer and integration issue between laboratory equipment and other informatics platform.
  • Collaborate with IT team to ensure network configurations, data security and data integrity are maintained per regulatory requirements.
  • Support Computer System Validation (CSV) activities.
  • Develop and maintain integration documents.
Requirements:
  • Hold Bachelor's degree in Life Sciences, Engineering or related field.
  • Have worked for at least 5 years IT systems and no less than 2 years in pharmaceutical, medical device or related environment.
  • Have hands-on experience with IT/OT system supporting and connected with QC laboratory equipment.
  • Have hands-on experience performing troubleshooting of QC laboratory equipment.
  • Preferably with hands-on laboratory equipment integration experience including with system such as CDS and/or weighing balance / scale software.
  • Preferably with experience in Windows OS especially in OS migration.
  • Preferably with knowledge of equipment connectivity protocols (e.g., TCP/IP, OPC, vendor API).
  • Understand computerised system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11) and industry best practice documents / standards (e.g., ISPE GAMP5).
Why Join ORKA:
  • Work that Matters: Support clients bringing innovative and life saving solutions to the population.
  • Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
  • Professional Environment: Work with similar professionals possessing Intelligent, Resourceful, Loyal and Teamwork characteristics.
  • Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.

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