![Delivery Centric Technologies](https://media.trabajo.org/img/noimg.jpg)
Senior Technical Consultant
vor 2 Wochen
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:
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_
*__ Cyber Security (Identity specialists)*_
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*__ Cloud Integration*_
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*__ 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
Job Types: Full-time, Permanent
Schedule:
Day shift
Experience:
total work: 1 year (Preferred)
Work Location: In person
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