Parexel is a leading global clinical research organization (CRO) committed to improving the world’s health. From clinical trials to regulatory consulting and market access, Parexel’s solutions are driven by a deep conviction in making a difference. Every team member contributes to developing therapies that benefit patients, working with empathy and dedication.
Job Description
The System Validation Services (SVS) Specialist II will support Parexel’s technology compliance by implementing standardized and risk-based validation strategies. This role ensures adherence to GxP requirements and quality standards while collaborating with technology teams to maintain compliance across Infrastructure Life Cycle, Software Development Life Cycle, and Technology Quality Life Cycle.
Key Responsibilities:
✅ Validation & Compliance:
- Lead validation tasks for Parexel’s systems using a risk-based approach.
- Provide validation guidance to ensure compliance with regulatory and quality standards.
- Conduct Periodic Reviews to verify system validation status.
✅ Risk Management:
- Support risk assessment and mitigation for technology solutions.
- Assist in audit/inspection readiness and response coordination.
✅ Process Improvement:
- Contribute to the development of Validation Framework Controlled Documents.
- Help create training materials for compliance processes.
✅ Administrative Support:
- Maintain accurate records, including timesheets and compliance documentation.
Skills & Qualifications
✔ Education:
- Bachelor’s degree in Technology, Biological Sciences, Pharmacy, or related field (or 3+ years of clinical research experience).
✔ Experience:
- Entry to mid-level experience in GCP, computerized system validation (CSV), and clinical trials (Phase I-IV).
- Familiarity with System Life Cycle (SLC) processes and GxP regulations.
- Basic knowledge of Lean Six Sigma, project management, and risk management.
✔ Soft Skills:
- Strong communication, organizational, and problem-solving abilities.
- Ability to work in a fast-paced, customer-focused environment.
- Self-motivated with a proactive approach to tasks.
