System Validation Services - Specialist II
System Validation Services - Specialist II
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Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
Our System Validation Services (SVS) team supports and improves the compliance of the companys technology solutions and technology solution offerings by standardized harmonized and streamlined validation/qualification activities based on the current GxP requirements and risk management principles.
This role will; 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 and offer expertise to ensure technology solution projects comply with established standards .
Key Accountabilities
Lead specific tasks for executing Parexel systems validation strategy.
Plan and oversee a riskbased approach to the validation of Parexel systems in support of 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 technologyrelated 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)
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/midlevel 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.
Highly motivated seeks opportunities for development clientfocused 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/midlevel 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.
Education:
Educated to degree level (technology biological science pharmacy or other health related discipline preferred) or equivalent qualification or 3 years clinical research experience.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
