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CSV Specialist, Life Sciences

Remote: 
Full Remote
Experience: 
Mid-level (2-5 years)
Work from: 
India

Katalyst HealthCares & Life Sciences logo
Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/
51 - 200 Employees
See all jobs

Job description

Responsibilies:
  • Implement and oversee the validation process for computer systems under GxP regulations.
  • Prepare and execute validation documents, including requirements compliance/validation plans, test protocols, test summary reports, and compliance/validation reports.
  • Review and approve system test and user acceptance test scripts, traceability matrix, and design specifications.
  • Ensure adherence to FDA guidance and industry standards such as GAMP.
  • Provide validation guidance, mely reviews, and Escalon's to TQ management.
  • •Work effectively with remote teams and manage multiple changes/projects simultaneously.
Requirements:
  • 2+ years of experience with System Development Lifecycle.
  • 3+ years of experience in Computerized System Validat i on.
  • Experience in the pharmaceutical, biotechnology, or medical device industries.
  • Proven experience in an FDA and/or globally regulated environment.
  • Strong knowledge of GxP standards and risk-based validation.
  • Proficiency with enterprise tools (JIRA, qTest, Iris/ServiceNow).
  • Excellent verbal and written communication skills.
  • Ability to lead a team or accomplish tasks independently.
  • Strong analytical skills and attention to detail.
  • Capability to work as a team player and manage tasks without supervision.
  • Flat hierarchies and responsibility from the beginning.
  • People-oriented culture.
  • Diversity and inclusion-focused environment.
  • Global client projects in a multinational environment.
  • Flexible working hours and home office.
  • Involvement in global conferences.
  • Individual professional development, training, and coaching.
Note:
  • US time zone. Mostly flexible timing.

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Systems DevelopmentComputer System ValidationFDA RegulationsRisk-Based TestingJIRAqTestServiceNow

Other Skills

  • Team Leadership
  • Communication
  • Analytical Skills
  • Teamwork
  • Detail Oriented
Are you interested?

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