Support Specialist, Computer Validation Systems

4 weeks ago

Singapore Hcl Singapore Pte. Ltd. Full time

As a System Infrastructure Support Specialist specializing in Computer Validation Systems, you will be responsible for ensuring the robustness, compliance, and functionality of computerized systems within the infrastructure. This role involves maintaining, validating, and troubleshooting systems to meet regulatory standards and support operational needs.

Key Responsibilities:

  • Maintain and administer computer validation systems, ensuring their reliability, security, and compliance with industry standards and regulations (e.g., FDA, GxP, etc.).
  • Develop, execute, and review validation protocols for computer systems, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Create and maintain documentation related to system configuration, validation procedures, and change management, ensuring adherence to regulatory guidelines.
  • Identify and resolve technical issues related to computer validation systems promptly, collaborating with cross-functional teams as necessary.
  • Conduct risk assessments to evaluate system vulnerabilities and implement mitigation strategies to ensure system integrity and data security.
  • Keep abreast of regulatory requirements and industry best practices, ensuring systems meet and exceed compliance standards.
  • Provide training and support to end-users and stakeholders on the use of validated systems, ensuring proper understanding and adherence to procedures.
  • Coordinate and implement system upgrades, patches, and modifications while maintaining system validation status.
  • Liaise with vendors for system support, upgrades, and issue resolution, ensuring service level agreements (SLAs) are met.
  • Identify opportunities for process improvements, efficiency enhancements, and cost optimization within the validated system environment.

Qualifications:

  • Bachelor's degree/Diploma in Computer Science, Information Technology, Engineering, or a related field.
  • Previous experience 3-5 in system infrastructure support with a focus on computer validation systems, preferably in a regulated industry (pharmaceuticals, healthcare, etc.).
  • Proficiency in validation methodologies, including IQ, OQ, PQ, and change control processes.
  • Excellent problem-solving skills and the ability to troubleshoot technical issues in validated systems.
  • Good communication skills with the ability to collaborate effectively with cross-functional teams.
  • Certifications in relevant areas (e.g., ITIL, Certified Validation Professional) are advantageous.
  • Role is located in Tuas

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