Compliance Expert – Pharmaceutical Industry
14 hours ago
Immerse yourself in delivering cutting-edge software systems that meet the stringent regulatory demands of the pharmaceutical industry. Join a talented team at the forefront of production software solutions and enjoy a flexible work week with room for a life in balance.
If you're passionate about ensuring compliance, you might be our new Compliance Expert.
Contribute to better patient safety
We provide 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 a Compliance Expert, you will collaborate with project managers, software developers, and customers' validation teams to guarantee that our solutions are compliant and meet customers' expectations so they can reuse our validation as their own.
Your primary responsibilities include:
- Participating in project execution and shaping a solution that meets regulatory requirements from the outset.
- Contributing to the design phase and assisting in writing Software & Hardware Design Specifications and a Requirement Traceability Matrix.
- Assisting in writing Test Plans in compliance with the customer's URS during the development phase.
In addition to this, you will support the rest of the organization in their daily tasks, including:
- Updating the validation documentation for our own software products as new features and versions are developed.
- Enhancing our Quality Management System (QMS) as we continually discover more efficient ways of working.
We want you to focus on doing what you do best, so expect minimal meetings and time-consuming processes.
You have the flexibility to choose whether you want to be based in our office in Aarhus or Hørsholm.
Experience with validation and technical projects
We envision that you:
- Hold a degree in a technical field and have an interest in technology.
- Have some experience with the validation process and understanding the requirements for compliance.
- Awareness of the technical deliverables for a project like URS, SDS, FS, RTM, Test Plans etc.
In addition to this, you:
- Exhibit high credibility and take pride in delivering high-quality projects.
- Work in a structured manner with an overview and attention to detail.
- Possess excellent communication skills and speak/write English at a professional level.
- Understand how to communicate with diverse profiles and navigate unexpected situations.
- Are a team player and actively participate in shaping the future direction of the team.
We encourage anyone qualified to apply 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 send your CV and a short application by email to Site Director Anders Rohde no later than May 31, 2024.
Start date is as soon as possible. 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
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