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Laboratory Computer System Validation Specialist 1

Covance 7/10/2018 6:03:26 PM
JOB ID: 21180 Category: Information Technology
Regional, Singapore

   

 

Job Overview

Play a pivotal role in the drug development process and grow your career

Are you interested in making an impact through your everyday work? Are you passionate about advancing your career while making a difference in patients' lives? Do you love to organize projects and thrive in a dynamic, high-paced environment?

If you said yes to these questions and you are looking for a place where you can explore a multitude of career paths across the drug development spectrum, consider working at Covance as a Laboratory Systems Validation Specialist. This is a permanent, full time position, based in our Singapore office.

As a computer systems validation expert you will collaborate with skilled IT technicians and laboratory teams to ensure the success of the operations and special projects.

In this position, you will be responsible for the following:

* Provide insight and guidance while leading system validations
* Responsible to participate in the assessment and description of, in close collaboration with the laboratory subject matter experts (SME), the expected behavior of the systems to automate some process steps and be able to translate them into formal requirements to whomever relevant (IT, person in charge of configuring rules...). These requirements will include potential changes/set-up needs outside of the middleware such as LIS to have the expected data workflow thanks to higher level understanding of data flow across systems
* Provide technical consultation, as needed, for both internal and external clients
* Ensures the collection of system requirements through communication with partners and documentation of system requirements according to specified methodologies, Experience with BABOK is a plus
* Owns and produces appropriate validation documentation and possesses Experience within a GxP and CAP/CLIA environment. Experience with SDLC and/or GAMP is a plus.
* Responsible to develop and lead test efforts for a variety of laboratory workflow and physical automation and lab instrument middleware platforms
* Works with GLSS and IT project managers and resources owners to coordinate resources for system test efforts
* Responsible for driving overall performance and delivery of on-time services
* Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.
* Responsible for ensuring client satisfaction
* Monitor execution of system testing according to specified metrics, identifies and resolves issues and challenges; raises issues as needed.
* Accountable for the pre-QA evaluation and treatment of system test results, ensuring appropriate and complete test packages for each system effort in which he/she is involved.
* Responsible for timely and efficient work output within each functional area in accordance with Covance quality standards.
* Ensures resources are sufficient to meet established performance and quality goals
* Ensures regulatory compliance
* Collaborate between the local department unit and counterparts at other sites and with other functional areas
* Coordinates the review, approval, and retention of validation documentation
* Provides written and verbal reports to project managers and/or GLSS leadership
* Responsible to execute all HR and training-related personnel tasks as defined by the company and department
* Provide a monthly report to the Manager.
* Support a culture of continuous improvement, quality and productivity

What we're looking for in you:

* Minimum of 3 years of Experience in a computer systems validation role
* Ability to requirement gather and test software
* Experience in 21 CFR regulation Part 11 (Data integrity)

Why people choose to work at Covance

"At Covance, it's our people that make us great – it's what our clients, our partners and, most importantly, what our employees say. Here, you'll have the opportunity to work with extraordinary people with diverse viewpoints. You'll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond."

Get to know Covance

Covance, the drug development business of LabCorp, is the world's most comprehensive drug development services company. Because of our broad Experience , from early research to commercialization, our more than 20,000 employees from across the globe are in a unique position to supply insights that go above and beyond testing. Our team's impact on healthcare is remarkable. Through their everyday work they've supported 100% of the top 50 drugs on the market and all the oncology drugs approved in 2016. Even though we span multiple businesses, we operate as one, sharing our knowledge to improve our efficiency and deliver on the promise of a healthier world.

The Covance team is driven by an energized purpose to improve health and improve lives across the globe. Here, you'll work alongside exceptional people who each play an important role in bringing new scientific discoveries and therapeutic area advancements to life. And, because we span the drug development spectrum, you'll directly impact a wide-range of initiatives as you explore unique career paths and discover your extraordinary potential.

Get ready to make a difference as we speed the delivery of groundbreaking therapies and improve lives of countless individuals.

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

Education/Qualifications

Minimum Required:
-Bachelor of Science (BS) or higher degree in a related area of study
-Background in information systems, data analysis, workflow analysis
-Ability to effectively communicate with our clients at all levels of the organizations and primarily within the laboratory

Experience

Minimum Required:
-3 to 5 years Experience in a Laboratory System Analyst or Laboratory System Validations role (or similar Experience ).
-Experience in IT/Computer validation (to leverage important inputs on how to handle the workflow, how to avoid data integrity problems, evaluate upfront solutions with less validation effort and capture any event possibility required by a system when setting complex rules)
-Experience in requirements gathering, documentation in a regulatory environment
-Strong knowledge of 21 CFR Part 11 requirements and CAP/CLIA regulations
-Strong command of written and spoken English

Preferred:
-Strong knowledge of lab workflow and processes
-Experience in software testing or audits is a plus but not required


Position Type: Full-Time

Location: Regional, SGP - Singapore



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).