Senior Technical Consultant

vor 2 Wochen

Sydney, Österreich Delivery Centric Technologies Vollzeit

Role: Senior Technical Consultant

Location: Sydney

Client: HCL

About Delivery Centric:

Delivery Centric is a customer focused, technology solutions provider for the APAC region. With a reputation for being a reliable, flexible and scalable partner. This is because we take great pride in delivering high quality outcomes at a competitive price. We offer a focused solution set of complimentary products & services for:

•_ *__Cyber Security (Identity specialists)*_

•_ *__Cloud Integration*_

•_ *__Cloud Solutions*_

through complete project delivery, managed services and professional services.

Job Description:

Responsibilities:

  • Possess 10+ years of experience in validating LIMS systems, instrument, and equipment qualification/validation
  • Demonstrate expertise in CSV activities for lab-related applications including LIMS, ELN (Electronic Lab Notebook), SDMS (Scientific Data Management System), CDS (Chromatography Data System), LES (Laboratory Execution System), and lab instruments and equipment systems
  • Conduct quality and compliance documentation reviews for GxP and non-GxP systems to ensure adherence to regulatory standards
  • Utilize Agile and Waterfall methodologies for software development compliance, with prior experience in CSV using Agile methodology
  • Review requirement specifications, functional specifications/user stories, and acceptance criteria to ensure completeness of test scripts with traceability
  • Conduct risk assessments for all requirements and design test cases based on identified risk levels
  • Review pre-executed test protocols for completeness, appropriateness, and availability of necessary test data
  • Review post-executed test protocols for accuracy, completeness of results, and evidence, and guide the defect management process
  • Author validation plans, compile validation summary reports, and generate Requirements Traceability Matrix (RTM)
  • Handle change requests, including implementation and closure, and ensure application controls and associated documentation processes are compliant
  • Review and ensure readiness of operational procedures for applications
  • Ensure document deliverables meet attribution, legibility, contemporaneousness, originality, and accuracy standards, including adherence to defined e-signature workflows
  • Manage implementation of change requirements for small changes, including implementation plan, impact assessment, test plan/results, defects, and RTM

For more information, reach out to Sadhana by sending your CV’S to sadhana.shivarudrappa@deliverycentric.com

Job Types: Full-time, Permanent

Schedule:

  • Day shift

Experience:

  • total work: 1 year (Preferred)

Work Location: In person

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