Computer System Validation Specialist
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Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
The Computer System Validation Specialist is responsible for developing and managing the validation documentation of all IT and collaborates with other departments for the validation of information systems. Ensures that all systems comply with regulatory requirements and implement periodic review procedures. The role reports to the ICT Associate Director.
The role is fully home based in Vietnam or Philippines.
Key Responsibilities
Manage validation activities and documentation for the IT systems (Validation Plans URS IQ/OQ/PQ UAT and reports)
Collaborate with IT QA and system stakeholders to ensure compliant validation processes
Oversee change control periodic reviews and software lifecycle documentation
Support deviation handling and CAPA management in line with quality standards
Ensure compliance with regulatory requirements
Participate in audits deliver CSV training and support regulatory updates
Maintain accurate tracking of activities and ensure completion of KPIs/KQIs and required trainings
Requirements
Masters or Engineering degree (preferred)
2 years of experience in a clinical research or GxP-regulated environment (preferred)
Strong knowledge of Computer System Validation (CSV) including software lifecycle and validation documentation
Good command of English (written and verbal) and proficiency in Microsoft Office
Strong organizational planning and communication skills
Teamoriented with the ability to collaborate effectively across functions
What we offer
Competitive salary
Full onboarding and training to ensure your success in the role
Long-term growth opportunities and a clear development path
The chance to work remotely
Who we are
Founded in 1998 in Italy and now operating at an international level OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.
OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing scientific and statistical consultancy for trial design regulatory activities pharmacovigilance etc.) always contributing to our clients challenging achievements.
The role is fully home based in Vietnam or Philippines.
Key Responsibilities
Manage validation activities and documentation for the IT systems (Validation Plans URS IQ/OQ/PQ UAT and reports)
Collaborate with IT QA and system stakeholders to ensure compliant validation processes
Oversee change control periodic reviews and software lifecycle documentation
Support deviation handling and CAPA management in line with quality standards
Ensure compliance with regulatory requirements
Participate in audits deliver CSV training and support regulatory updates
Maintain accurate tracking of activities and ensure completion of KPIs/KQIs and required trainings
Requirements
Masters or Engineering degree (preferred)
2 years of experience in a clinical research or GxP-regulated environment (preferred)
Strong knowledge of Computer System Validation (CSV) including software lifecycle and validation documentation
Good command of English (written and verbal) and proficiency in Microsoft Office
Strong organizational planning and communication skills
Teamoriented with the ability to collaborate effectively across functions
What we offer
Competitive salary
Full onboarding and training to ensure your success in the role
Long-term growth opportunities and a clear development path
The chance to work remotely
Who we are
Founded in 1998 in Italy and now operating at an international level OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.
OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing scientific and statistical consultancy for trial design regulatory activities pharmacovigilance etc.) always contributing to our clients challenging achievements.
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Manager
