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Software Validation Specialist
Job in
Washington, District of Columbia, 20022, USA
Listed on 2026-10-02
Listing for:
somewhere
Full Time
position Listed on 2026-10-02
Job specializations:
-
Software Development
Software Testing
Job Description & How to Apply Below
Software Validation Specialist - Position Open for LATAM Region and The Philippines
100% Remote
Salary Range: $3,000 - $4,000 Usd
Type of
Contract:
Independent Contractor Agreement
The company do research and development (R&D) company specializing in novel devices and drugs for the treatment of cancer and other diseases
Duties and ResponsibilitiesDevelop and execute validation plans and strategies for software systems, including risk assessments and test scripts.
Ensure software systems comply with relevant industry regulations, standards, and guidelines, such as GAMP5, 21 CFR Part 11, and ISO 13485.
Collaborate with cross-functional teams to gather and document user requirements and translate them into validation criteria.
Design and perform validation tests, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
Create and maintain validation documentation, including validation reports, traceability matrices, and validation protocols. Especially important is the development of standardized templates that the company can use for all software validation activities.
Manage software change control processes and assess the impact of changes on validated systems.
Conduct risk assessments to identify and mitigate potential software validation issues.
- Minimum of 3 years of experience in software validation
- Hands-on experience validating software in accordance with GAMP5 guidelines
- Strong understanding of software validation methodologies and regulations
- Proven ability to develop , plan, and execute validation strategies for software systems
- Experience conducting risk assessments and creating validation test scripts
- Ability to collaborate with cross-functional teams to gather user requirements and translate them into technical validation criteria
- Experience in managing software change control processes, including evaluating the impact of system changes on previously validated systems.
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