Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Responsibilities
7-10 years’ experience in Computer System Validation of EMS and Client applications.
Must have experience in Agile methodology and handled multiple releases in parallel.
Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/Client, project management, test script review, test execution review, test defect management.
Has working experience in any one or two of the following domains Tool validation like Service now, Automation tools, JIRA.
Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC.
Application of FDA guidance’s and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams.
Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report.
Must be familiar with procedures, work instructions, forms and templates.
Solid understanding of SDLC, Jira, QTest, automated test tools, code repository like bitbucket and change control/ management systems like ServiceNow.
Additional Information
All your information will be kept confidential according to EEO guidelines
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