Lims Consultant- Csv

2 weeks ago

Sydney, Australia Resource Corner IT Consulting service Full time

New Billing/ Potential/ Non
- Exclusive

Computer System Validation, LIMS validation, Lab Instrument & Equipment qualification & validation

Keywords

CSV, Computer System Validation, LIMS, Lab Instrument Validation, Equipment validation, Calibration,

Roles and Responsibilities
- 10+ years’ Experience in the Validating LIMS systems, Instrument and Equipment qualification/validation
- Perform Quality and Compliance documentation review for GxP and non-GxP systems to ensure compliance with regulatory requirements
- Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology
- Reviews - Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test script with traceability
- Ensures Risk Assessment is completed for all the requirements and test cases are designed In reference to the risk levels identified for the requirements
- Performs review of pre-executed test protocol which includes all the basic elements of a test script, completeness and appropriateness of the test case to the requirement
- Ensures pre-executed test protocol has the necessary test data requirements to run the tests
- Reviews post-executed test protocols for the completeness, accuracy of the results and evidence and enables team on the defect management process
- Able to author Validation Plan and compile Validation Summary Report and generates RTM
- Ensures that the document deliverables are Attributable, Legible, Contemporaneous, Original and Accurate and if any e-Signatures are applied then they are applied as per the defined workflows
- Is able to handle Change Requirement related implementation for small changes - responsible for Implementation Plan, Impact Assessment, Test Plan/ Results, Defects and RTM
- Prior experience in using tools like ALM, DMS and JIRA

**Job Types**: Full-time, Permanent

**Salary**: $100,000.00 - $130,000.00 per year

Schedule:

- 8 hour shift

**Experience**:

- Laboratory information management systems: 8 years (required)
- CSV: 10 years (required)

Work Authorisation:

- Australia (required)

Work Location: In person

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