Software Validation Specialist

Position Open for LATAM Region and The Philippines

100% Remote


Position: Software Validation Specialist

Salary Range:  $3,000 - $4,000 Usd 

Type of Contract : Independent Contractor Agreement 

About the Company

•  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 responsibilities:

1. Understanding how to validate software using the principles of GAMP5 Categories 3, 4, or 5.

1. Validation Planning: Develop and execute validation plans and strategies for software systems, including risk assessments and test scripts. 

1. Compliance Assurance: Ensure software systems comply with relevant industry regulations, standards, and guidelines, such as GAMP5, 21 CFR Part 11, and ISO 13485. 

1. Requirements Analysis: Collaborate with cross-functional teams to gather and document user requirements and translate them into validation criteria. 

1. Validation Testing: Design and perform validation tests, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).

1. Documentation: 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.
    
2. Change Control: Manage software change control processes and assess the impact of changes on validated systems.
    
3. Risk Assessment: Conduct risk assessments to identify and mitigate potential software validation issues.

Requirements:

• 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.