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Sr Clinical Specialist Testing

2.00 to 4.00 Years   Bangalore   25 Apr, 2019
Covance India Pharmaceutical Services Private Limited
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
Industryharma / Biotech
Functional AreaGeneral / Other SoftwareTesting
EmploymentTypeFull-time

Job Description

Job OverviewGlobal Specimen Solutions (GSS) is wholly owned company of Covance Inc., providing specialty services in the holistic specimen tracking space. GSS improves translational science 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/QualificationsMinimum Education Required:
  • BS/BA degree preferably in the sciences or related field, or two (2) years in a validation or regulatory position dealing with SOPS and computer systems requirement specification.
Experience Required:
  • Candidate should be okay working in 2 PM to 11 PM shift
  • Minimum 2 years to 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.

Keyskills :
fdagcpcrojirasops1cfrclinicallabepa21cfrpart11svttestgcpenvironmentclinicalmonitoringsoftwaretestlead

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