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Senior Clinical Systems Specialist (Testing) - GSS

Covance 4/23/2019 10:06:04 AM
JOB ID: 30180 Category: Other
Bangalore, India

   

 

Job Overview

Covance's Global Specimen Solutions (GSS) business provides specialty services in the holistic specimen tracking space. GSS improves translational science in the drug discovery process through industry best practices and a uniquely powerful pipeline data management analytics solution. GSS reduces the time, cost and risk of specimen based research, while building robust, healthy data pipelines that optimize research opportunities.

Job Summary

* Reviews software user stories and scenarios for accuracy and completeness.
* Creates test cases from reviewed software user stories and scenarios that validate scenario outcomes.
* Reviews test cases created by other software test leads or software test specialists with regard to their accuracy in validating the outcomes of the associated user stories and scenarios.
* Executes test cases created by other software test leads or software test specialists and gathers necessary documentation as guided by test case.
* Maintains and utilizes a strong knowledge of SOPS and validation work procedures/standards in relation to the System Development Life Cycle

Essential Job Duties:

Function Specific

* Demonstrate the ability to multi-task and manage validation activities for a project effectively.
* Plan and establish timelines to meet or exceed business expectations for validations.
* Review product specification documentation to create appropriate testing methodologies.
* Review validation documentation to support projects.
* Work with other team members to create appropriate testing environments to support the testing methodologies.

* Utilize strong working knowledge of SOPs, validation standards, and work procedures to suggest potential improvements and to provide training and guidance to all staff.

Customer Facing

* There are no customer facing job functions in this position.

Metrics

* Support management of metrics.
* Assist with investigating or resolving issues of quality as directed.

Staff and Financial Management

* Understand implications of activities to project budgets.

Process Improvement

* Suggest process improvements where issues are seen.
* Support Six Sigma process improvement teams.

Training / SOPs

* Reviews training materials for staff.
* Mentor and support other clinical employees in their understanding and adoption of validation concepts and responsibilities.
* Active member of SOP review teams as assigned.

Other

* Lead or assist with special projects as designated.
* Perform other duties as assigned by management.

Principal Contacts and Scope of Communications

* Internal: Software Test Lead, IT Project Manager, IT Business Analyst, IT Software Engineer, Product Owner, SVT Test Lead
* External: None

Education/Qualifications

Minimum Education Required:

* BS/BA degree preferably in the sciences or related field, or four (4) years in a validation or regulatory position dealing with SOPS and computer systems requirement specification.

Experience

Minimum Required:

* Candidate should be okay working in 2 PM to 11 PM shift
* Minimum 4 years validation Experience or equivalent work Experience in a regulated (FDA, EPA, etc.) environment preferred.
* Strong attention to detail.
* Strong analytical skills, preferably in a GCP environment.
* Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry.
* Problem Solving/Logic Skills.
* Strong communication and interpersonal skills.
* Strong MS/Office skills in particular with Excel and Word.
* Understanding of Electronic Software Validation systems, such as JIRA or Target Process preferred.


Position Type: Full-Time

Location: Bangalore, IND - India



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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).