Job Description
We are seeking a highly skilled Software Validation Expert to join our team. As a key member of our organization, you will be responsible for setting up and maintaining our CSV validation platform, identifying issues, and enhancing the quality of our software stack in compliance with cGMP guidelines and internal practices.
Main Responsibilities:
* Developing, testing, and implementing critical software applications that support the business;
* Ensuring change requests are controlled, tested, and validated according to the latest regulatory guidance and industry best practices;
* Promoting a continuous improvement culture and mitigating complexity;
* Ensuring knowledge transfer and documentation;
* Preparing and reviewing applicable procedures and process-related documentation (IOP, SOP, and COP);
* Maintaining accurate and up-to-date validation documentation;
* Recommending and implementing process upgrades and efficiency improvements;
* Involvement in both internal and external audits as required;
* Ensuring all assigned tasks are planned and delivered on time, safely, efficiently, reliably, and cost-effectively.
Required Skills and Qualifications:
* University degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or equivalent scientific area;
* Experience in a scientific area in analytical chemistry (preferentially) and qualification & validation;
* Computer and mathematical logic knowledge;
* Knowledge of software applications supporting laboratory work related to Empower (preferentially);
* Analytical skills;
* Good communication skills;
* Written and oral English;
* Team working ability;
* Solution-driven personality;
* Critical and proactive nature;
* Accuracy and responsibility.
Benefits:
* Full-time opportunity;
* Remuneration and social benefits adjusted to the job function and matching experience;
* Excellent work environment with a strong focus on quality.