Computer System Validation
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Job Location:
Jersey, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Title : Computer System Validation
Location : Remote
Location : Remote
Project Overview
Validate and document software installed on laboratory instruments in alignment with EMA regulatory guidelines.
Transition the management of instrument software to PPD IT software management SOPs.
Capture and document current software requirements configurations and operational details.
Key Responsibilities
Collect and document business and technical requirements.
Develop and maintain software validation test cases.
Prepare detailed software specifications and related documentation.
Design infrastructure and data flow diagrams.
Conduct comprehensive risk assessments related to software and system configurations.
Required Skills
Strong technical writing and documentation skills.
Excellent verbal and written communication abilities.
High attention to detail and strong organizational skills.
Validate and document software installed on laboratory instruments in alignment with EMA regulatory guidelines.
Transition the management of instrument software to PPD IT software management SOPs.
Capture and document current software requirements configurations and operational details.
Key Responsibilities
Collect and document business and technical requirements.
Develop and maintain software validation test cases.
Prepare detailed software specifications and related documentation.
Design infrastructure and data flow diagrams.
Conduct comprehensive risk assessments related to software and system configurations.
Required Skills
Strong technical writing and documentation skills.
Excellent verbal and written communication abilities.
High attention to detail and strong organizational skills.
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Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
