Senior Computerized System Validation Analyst


The Senior CSV Analyst works in close collaboration with the Associate Director, CSV. The Senior CSV Analyst act as lead person in the CSV tasks including validation planning and reporting, developing quality validation package for GxP computerized systems, Internal/External Audit support, NC/CAPA support to QA, training, collaboration with operations, IT, QA, and vendors. This role will ensure that validation package for GxP computerized systems used at Innovaderm, are established to ensure data integrity and GxP compliance to regulations and industry best practices.

 

RESPONSIBILTIES

 

More specifically, CSV Analyst:

  • Establishes computerized system validation schedule for key deliverables with the system owners and functional departments.
  • Determines the extent of system validation based on the policy, standard operating procedures (SOPs), system type and risk-assessment.
  • Leads the development/writing of the validation packages including but not limited to user requirement specification (URS), ERES, risk assessment, configuration manual, validation plan, test scripts, traceability matrix, validation summary report.
  • Assesses the completeness of validation packages of computerized system providers to determine if can be used to support Innovaderm validation (e.g., IQ, OQ).
  • Review and assess post-validation changes (upgrades/enhancements/bug fixes) to GxP systems (change control).
  • Lead System Retirement activities (planning, execution, and reporting) for GxP computerized systems to be retired.
  • Provide support and guidance to the system owners/system administrators for their responsibilities for the management of computerized systems (e.g., periodic review).
  • Peer review of validation packages to ensure data integrity and GxP compliance.
  • In collaboration with Associate Director, CSV, prepare an annual plan for CSV projects in pipeline and support in resource planning for the planned projects.
  • Act as a reference person for consultations regarding validation of computerized systems.
  • Train CSV/QA team members, business users, IT SMEs or vendor(s) on the concepts of CSV, as and when required by projects.
  • Mentor CSV Analyst(s) to groom them on CSV subject matter as well as latest industry trends.
  • Participate to the establishment/review of SOPs and process improvement initiatives.
  • Contribute to training content related to the computerized systems aspects.
  • 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 5 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 schedule
  • Vacation
  • Home-based position
  • Ongoing learning and development

 

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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