Systems Validation Specialist II

Remote: 
Full Remote
Contract: 
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Offer summary

Qualifications:

Bachelor's degree in technology, biological science, pharmacy, or a health-related discipline preferred., 3+ years of experience in clinical trials and/or clinical research with a focus on GCP and technology compliance., Entry to mid-level experience in computer technology quality and compliance, including computerized system validation., Excellent interpersonal, verbal, and written communication skills..

Key responsibilities:

  • 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.

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Parexel XLarge http://www.parexel.com
10001 Employees
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Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's 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 we're committed to making a difference.

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.

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Communication
  • Organizational Skills
  • Social Skills
  • Self-Motivation

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