Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Systems Validation Specialist II
Job ID R0000033147 , MexicoWe 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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