QA Engineer – ensure compliance to pharma regulations

Do you want to play a key role in delivering software systems that are in compliance with the regulatory demands of the pharmaceutical industry? Do you want to be part of a talented team in a company at the forefront of production software solutions? And do you dream of a flexible work week with room for a life in balance?

If that’s three times yes, you might be our new QA Engineer.

Work for better patient safety
We provide globally leading pharmaceutical companies with end-to-end production software solutions – standardized and custom – within data collection & decision support, traceability, digital print, vision inspection, and automated test.

As QA Engineer you will work together with project managers, software developers and our customers’ validation teams to ensure that our solutions are compliant and live up to the customers’ expectations so they can re-use our validation as their own.

In between projects you will work on our ISO 9001 and ISO 14001 certified Quality Management System. You will also work with our product development teams ensure that products and services meet regulatory demands and can be used in projects with minimal validation efforts.

Your primary responsibilities are:

• Participating in project execution. You will be involved from the beginning and help shape a solution that meets regulatory demands.
• Participate in the design phase and help write Software & Hardware Design Specifications and a Requirement Traceability Matrix.
• Participate in the development phase and help write Test Plans in compliance with the customer’s URS.

In addition to this, you will support the rest of the organization in their day-to-day tasks, including:

• Update the validation documentation for our own software products as new features and versions are developed.
• Update our QMS as we continuously find more efficient ways of working.

We want you to focus on doing what you do best, so expect that meetings and time-consuming processes are kept to an absolute minimum.

You choose whether you want to be based in our office in Aarhus or Hørsholm.

Experience with validation and technical projects
We imagine that you

• hold a degree in a technical field and have an interest in technology
• have some experience with the validation process and what it takes to be compliant
• know your way around a the technical deliveries for a project like URS, SDS, FS, RTM, Test Plans etc.

In addition to this, you

• have a high degree of credibility and take pride in delivering high-quality projects.
• work in a structured way with overview and attention to detail.
• possess excellent communication skills and speak/write English at a professional level.
• understand how to communicate with different profiles and navigate unexpected situations.
• are a team player and actively participate in developing the future direction of the team.

We encourage anyone qualified to apply for the position regardless of age, gender, religion, or ethnicity.

Adapt your schedule to fit your lifestyle
You are the expert on what makes you happy and efficient. So, whether that entails a 4-day work week or working in the evening or from home that is simply how you will be working.

Ready to reimagine the pharmaceutical industry?
Please apply for the position by sending your CV and a short application by email to Site Director Anders Rohde at [email protected] no later than May 31, 2024.

Start date is as soon as possible. Please note that we will conduct interviews on an ongoing basis.

If you have any questions, please feel free to call Anders on +45 28118858.

We look forward to hearing from you!