The Computerized Systems Quality Assurance (CSQA) Specialist works in close collaboration with the Associate Director, Quality Systems, the CSV team, and system owners. The CSQA Specialist can participate in the general tasks including quality document revision, RFI/client qualification, training management, vendor management, systems compliance but will be dedicated to the area of specialty defined in Specialty section.

More specifically, the CSQA Specialist:

• Collaborates closely with CSV team, IT team and System owners/SMEs to ensure quality standards, regulations and procedures are followed through the lifecycle of clinical systems. For more details, see specialty section.
• Participates as a SME in internal audits, client audits, vendor audits and regulatory inspections.
• Performs quality system 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).
• Performs audit activities such as planning, conducting and report writing (internal, vendors, computerized systems). Takes a risk-based approach for the verification to be performed.
• Contributes to consultation on computerized systems related issues. Can participate to process improvement initiatives.
• Contributes 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

Computerized Systems

• Assesses and ensures 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.
• Reviews/approves 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.

IDEAL PROFILE

Education

• Bachelor degree in a relevant discipline or equivalent experience;

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;
• Prior experience in developing, reviewing, and approving validation documentation for GxP Computerized Systems;
• 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 detail;
• 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.