CSV Lead

Job Description

Job DescriptionCompany Description

• 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

Roles & 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.