Senior Technical Specialist - Lims Validation

We are HCLTech, one of the fastest-growing large tech companies in the world and home to 219,000+ people across 54 countries, supercharging progress through industry-leading capabilities centered around Digital, Engineering and Cloud.

The driving force behind that work, our people, are diverse, creative, and passionate, raising the bar for excellence on a regular basis. We, in turn, work hard to bring out the best in them as we strive to help them find their spark and become the best version of themselves that they can be.

We are on the lookout for a highly talented and self-motivated Senior Technical Specialist - LIMS Validationto join us on our journey in advancing the technological world through innovation and creativity.

At HCLTech Australia, we value the unique perspective and contributions of all individual and we actively encourage applications from Aboriginal and Torres Strait Islander people to apply for this role.

Are you ready to be an important part of this ever-transformational journey?

Senior Technical Specialist - LIMS Validation

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 
• Experienced in CSV activities in Lab related applications like LIMS, ELN, SDMS, CDS, LES, Lab Instruments and Equipment systems and has a clear understanding of various Lab systems and processes.
• Perform Quality and Compliance documentation review for GxP and non-GxP systems to ensure compliance with regulatory requirements.
• Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis of the documentation process.
• 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.
• Performs Change Requests – Implement and Close Change Request which includes to check for the application controls and associated documentation process for end-to-end Change Request process.
• Reviews and ensures that the Operational Procedure for the application is ready.
• 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

Why Us 

We are one of the fastest-growing large tech companies in the world, with offices in 50+ countries across the globe and 219,000 employees. 

• Our company is extremely diverse with 165 nationalities represented.
• We offer the opportunity to work with colleagues across the globe. 
• We offer a virtual-first work environment, promoting a good work-life integration and real flexibility. 
• We offer comprehensive benefits for all employees.  
• We are a certified great place to work and a top employer in 17 countries, offering a positive work environment that values employee recognition and respect. 

Equality & Opportunity for All 

Representing 165 nationalities across the globe, we pride ourselves on being an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, Aboriginal and Torres Strait Islander people or any other protected classification, in accordance with federal, state, and/or local law.

Note: Please follow the link to apply to the role with your recent resume. If you need more details, feel free to contact Nicy on ***********@hcl.com.

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