Systems Validation Specialist II
Mexico, RemoteJob ID R0000033147 Category Quality Management
About this Role
We are seeking a System Validation Specialist to join our SVS team. This role will support and improve the compliance of our technology solutions by implementing standardized, harmonized, and streamlined validation/qualification activities based on current GxP requirements and risk management principles.
Key Responsibilities:
Validation Representative
- Lead specific tasks in executing Parexel's system validation strategy.
- Plan and oversee risk-based approaches to system validation.
- Provide validation consultancy and guidance to ensure regulatory compliance.
- Conduct periodic reviews to verify the maintained validated state of technology solutions.
- Support risk management activities to identify, assess, and control technology-related risks.
- Assist with audit/inspection preparation and support.
- Contribute to data collection and review of Requests For Information (RFI).
Standards & Quality Framework
- Assist Process Owners and Stakeholders in developing and maintaining Validation Framework Controlled Documents.
- Contribute to the development and maintenance of Managed Information supporting the Validation Framework.
- Help develop and deliver training materials for the Validation Framework.
Required Skills:
- Entry to mid-level experience in computer technology quality and compliance, including computerized system validation.
- Basic knowledge of continuous improvement methodologies.
- Competency in core project management activities.
- Excellent interpersonal, verbal, and written communication skills.
- Strong organizational and prioritization abilities.
- Ability to work in a fast-paced, customer-focused environment.
- Self-motivated with a desire for professional development.
- Cultural awareness and ability to think and work globally.
- Intermediate proficiency in desktop software (MS Office, Excel, Adobe PDF, etc.)
Knowledge and Experience:
- 3+ years of experience in clinical trials and/or clinical research, with emphasis on GCP and technology compliance.
- Familiarity with technology related to clinical trial activities, including System Life Cycle processes and applicable GCP regulations.
- Entry-level knowledge of project management, Lean Six-Sigma, auditing, and/or risk management methodologies.
Education:
- Bachelor's degree in technology, biological science, pharmacy, or other health-related discipline preferred.
- Equivalent qualification or 3+ years of clinical research experience will be considered.
- Good English skills.
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