System Validation Services - Specialist II

The System Validation Services (SVS) team supports and improves the compliance of the company’s technology solutions and technology solution offerings by standardized, harmonized, and streamlined validation/qualification activities based on the current GxP requirements and risk management principles.

Support efforts to define, adopt, and oversee compliance to processes and standards as the fundamental baseline for Infrastructure Life Cycle, Software Development Life Cycle, Technology Quality Life Cycle and delivery. Supports efforts, in collaboration with the business to monitor, identify and implement continuous process improvement across all technology business units.

Supervise and ensure the effective implementation of technology solutions for quality management, aiding in delivering products and services to customers. Offer expertise to ensure technology solution projects comply with established standards.

Key Accountabilities:

Accountability

Validation Representative

• Lead specific tasks for executing Parexel system’s validation strategy.

• Plan and oversee a risk-based approach to the validation of Parexel systems, in support the Technology Solution Validation Team.

• Support the provision of validation consultancy, guidance and oversight to ensure compliance with applicable regulatory and quality requirements, and applicable Policies and SOPs.

• Conduct Periodic Reviews to verify the validated state of each technology solution has been maintained and report findings.

• Support risk management activities to identify, assess, and control technology-related risks eliminating risks or reducing risks to an acceptable level.

• Assist with logistical support and initial planning for audit/inspection hosts and provides standard presentation for covering Infrastructure Life Cycle, Software Development Life Cycle and Technology Quality Life Cycle in audit.

• Assists audit/inspection hosts with data collection and initial collation for the responses.

• Support activities for development of risk management processes in line

• Assist with data collection and initial review of Requests For Information (RFI).

• Performs general and administrative tasks including accurate and timely completion of timesheet.

Standards & Quality Framework

• Assists Process Owners and Stakeholders to support the design, development, implementation, and maintenance of Validation Framework Controlled Documents.

• Contribute to the development and maintenance of Managed Information and guidance in support of the Validation Framework.

• Contribute to the development and delivery of training material in support of the Validation Framework.

Skills:

• Entry/mid-level experience in computer technology quality and compliance (including computerized system validation) and the pharmaceutical industry across multiple disciplines within Clinical Drug Development (Phase I/II/III/IV) and/or Manufacturing.

• Basic knowledge of continuous improvement methodologies.

• Exhibits competency across core project management activities.

• Excellent interpersonal, verbal and written communication skills, business understanding, negotiation skills and strong organizational skills.

• High ability to work in a customer-focused, fast-paced and rapidly changing environment with the high ability to prioritize workload and manage multiple and varied tasks with enthusiasm and some supervision.

• Highly motivated, seeks opportunities for development, client-focused, having the ability to work with guidance on own initiative.

• Exhibits a sense of urgency when addressing problems and ensures completion of commitment.

• Culturally aware and ability to think and work globally.

• Intermediate desktop software skills (MS Office, Excel, Adobe PDF etc.).

Knowledge and Experience:

• Entry/mid-level Clinical trials and / or Clinical trials and /or research work experience required, with emphasis on GCP and technology compliance.

• Familiar in technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems.

• Entry knowledge of project management, Lean Six-Sigma, auditing and/or risk management methodologies.

Education:

• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification, or 3+ years clinical research experience.