Tecnimede Group is a Portuguese multinational company, with more than 40 years of history in the life cycle of the drug product for human use — development, production, promotion and marketing – with the mission to improve and preserve the human life and the human health.
Exporting to more than 100 countries worldwide, it is present in 6 countries (Portugal, Spain, Italy, Morocco, Colombia and Brazil) with a strong focus in expanding internationally and building strategic partnerships.
System Validation Specialist – Computerized Systems
Will be responsible to setup and maintain CSV validation platform, to identify issues and help increase the quality of the software stack being developed in terms of compliance with cGMP guidelines and alignment with the internal practices, focusing on continuously improving implemented processes with the goal to achieve the most efficient solution, defining standards, implementing and monitoring adherence through pre-defined KPIs at all Tecnimede sites.
Main responsibilities:
- Develop, test and implement critical software applications that support the group with support of Project Management and IT department;
- Ensure that the change requests are duly controlled tested and validated as per the latest regulatory guidance and industry best practices;
- Promote a continuous improvement culture, mitigating any tendency for complexity;
- Ensure a know how transfer and respective documentation;
- Prepare and review applicable procedures and process related documentation (IOP, SOP and COP);
- Maintain accurate and up to date the validation documentation;
- Recommend and implement processes upgrades and improvements in efficiency;
- Involvement in both internal and external audits as required;
- Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner.
Profile:
- University degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or equivalent degree in a scientific area;
- Experience in a scientific area in analytical chemistry (preferentially) and qualification & validation;
- Computer and mathematical logic knowledge;
- Knowledge of software applications that support laboratory work related with Empower (preferentially);
- Analytical skills;
- Good communication skills;
- Written and oral English;
- Team working ability;
- Solution driven;
- Critical and proactive personality;
- Accuracy and responsibility.
We offer:
- Full time opportunity;
- Remuneration and social benefits adjusted to the job function and matching the experience;
- Excellent work environment, with a strong focus on quality.
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