QC Systems Specialist
17 hours ago
- 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.
- 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).
- 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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