Location: Canada Québec   Type: Full Time

SUMMARY

What is validation?

Optel is a company offering tracking and traceability solutions for companies in various fields including large pharmaceutical companies. The pharmaceutical industry is governed by numerous regulatory requirements from organizations such as the FDA (U.S.A.) and EMA (Europe). This therefore requires providing clear, detailed and rigorous documentation.

Our business sector is responsible for validating software as well as deploying it to our customers, according to specific standards.

Validation helps ensure and confirm that software is doing the right thing in accordance with applicable laws, in all possible situations. Deployment requires working with customers to obtain the necessary requirements for the successful delivery of the software.

This work will allow you to live with the regulated pharmaceutical field and its validation and deployment requirements. You will be called upon to generate validation documents such as functional specifications (FS), configuration and design specifications (CSDS), installation and operational qualification (IOQ) protocols, as well as change controls. You will be called upon to support software deployment activities such as the review of customer requirements and the review of test executions.

You will also be able to run and review validation protocols by performing required tests for software.

This job is a unique opportunity to work in a high demand field that is not taught in university. The high level of regulation requires skilled people to ensure that we deliver quality software.

REQUIREMENTS

- Oral and written bilingualism (French/English)

- Knowing how to work and operate systems such as JIRA, Sharepoint, Office Suite

- Good knowledge or understanding of software business processes (data flow)

- Technical drafting of documents

- Teamwork

- Autonomy

- Ease of learning

- Resourcefulness

WHAT WE OFFER

- Flexible hours

- Possibility to work in the office or in hybrid mode

- Bright and ergonomic workspaces

- Free parking with electrical terminals

- Refund of 50 % of the RTC monthly passes

- Free coffee and fruits