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Computerized Systems Validation Analyst


 

The role of the CSV Analyst is to establish quality validation packages for the GxP systems used at Innovaderm with the goal of ensuring data integrity and compliance with the regulatory and industry requirements.

 

More specifically, the CSQA Specialist:

 

Computerized Systems tasks

  • Assess and ensure Data integrity and GxP compliance for clinical systems in alignment with industry regulations.
  • Provides quality and compliance oversight for the qualification, and validation, of computerized systems against industry regulations and best practices.
  • Review/approve Validation Documentation including but no limited to: Risk assessment, Validation Master Plans, User Requirements, Functional Requirements, Configuration Specification, IQOQPQ, Traceability Matrix, Validation Summary Reports and Change Controls for Clinical systems.
  • Oversees Investigation/CAPA related to GxP Computerized Systems.

 

General tasks

  • Collaborate closely with CSV team, IT team and System owners/SMEs to ensure quality standards, regulations and procedures are followed through the life cycle of clinical Systems. For more details, see section specialty.
  • Participate as a SME in internal audits, client audits, Vendor audits and regulatory inspections
  • Performs quality systems tasks such as writing/revision of quality documents.,
  • Executes internal audits or audits in the area of specialty in accordance with the established audit program. Can act as a subject matter expert (SME).
  • Perform audit activities such as planning, conduct and report writing (internal, vendors, computerized systems). Takes a risk-based approach for the verification to be performed.
  • Contribute to consultation on computerized systems related issues. Can participate to process improvement initiatives.
  • Contribute to training content related to the compliance aspects of computerized systems. Can provide training to Innovaderm employees.
  • Completes/revise RFI for potential client in his area of expertise. Can participate to client qualification audits and regulatory inspections including mock inspection activities.
  • Provides solutions to a wide range of problems through individual efforts in a creative, thorough, practical, and consistent fashion in line with applicable regulations

 

IDEAL PROFILE

 

Education

 

  • Bachelor’s degree in computer science, engineering life science or related field.
  • Equivalent experience and/or will be also considered.

 

Experience

 

  • Minimum of 3 years of experience in Computerized Systems validation in the GxP industry; prior experience with clinical platforms is an asset (e.g., IWRS, EDC, ePRO/eCOA, eConsent).

 

Knowledge and skills

 

  • Excellent knowledge of regulations and guidelines related to computerized systems validation (US FDA 21 CFR part11, EU annexe 11, Health Canada, GDPR, ICH.
  • Strong technical knowledge to provide concise and clear documentation, verbal communication, interpersonal and problem-solving skills.
  • Ability to work independently.
  • Good knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint) and other tools used in CSV (e.g., JIRA, HPALM, DMS).
  • Good organization skills and ability to adapt to a rapidly growing environment.
  • English, written and spoken.
  • Experience in writing & reviewing SOPs for accuracy and GxP compliance.
  • Organizational abilities to meet accelerated timelines, manage multiple shifting priorities and maximize efficiencies in a dynamic customer-focused environment.
  • Superior attention to details.
  • Critical-thinking and problem-solving skills; ability to recognize and resolve discrepancies and issues.

 

OUR COMPANY

 

The work environment

 

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

 

In this position, you will be eligible for the following perks: 

  • Flexible work schedule
  • Home-based

 

 

Work location

 

Note that this opening is for a home-based position in India. 

 

 

About Innovaderm

 

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

 

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Innovaderm only accepts applicants who can legally work in India.

 

 

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