Software validation specialists 1
Software validation specialists 1
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Job Description
Position Open for LATAM Region and The Philippines
100% Remote
Position: Software Validation Specialist
Salary Range: $2800 $3500 Usd
Type of Contract : Independent Contractor Agreement
About the Company
The company specializes in providing cloudbased telemedicine solutions. Offering a comprehensive platform designed to streamline and the delivery of virtual healthcare services. The services typically include features such as secure video consultations appointment scheduling patient management and electronic health record integration.
The company aims to improve access to healthcare by enabling medical professionals to connect with patients remotely thus supporting efficient and effective healthcare delivery.
Duties and responsibilities:
- Understanding how to validate software using the principles of GAMP5 Categories 3 4 or 5.
- Validation Planning: Develop and execute validation plans and strategies for software systems including risk assessments and test scripts.
- Compliance Assurance: Ensure software systems comply with relevant industry regulations standards and guidelines such as GAMP5 21 CFR Part 11 and ISO 13485.
- Requirements Analysis: Collaborate with crossfunctional teams to gather and document user requirements and translate them into validation criteria.
- Validation Testing: Design and perform validation tests including IQ (Installation Qualification) OQ (Operational Qualification) and PQ (Performance Qualification).
- 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.
- Change Control: Manage software change control processes and assess the impact of changes on validated systems.
- Risk Assessment: Conduct risk assessments to identify and mitigate potential software validation issues.
Requirements:
- Minimum of 3 years of experience in software validation
- Handson 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 crossfunctional 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.
Employment Type
Remote
Company Industry
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
