System Validation Specialist (M/F)

Tecnimede Group; Sintra; On-site; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Full-time opportunity

Competitive remuneration

Excellent work environment

Job summary

Tecnimede Group in Sintra (Lisboa) is seeking a System Validation Specialist to join our team. You will set up and maintain the CSV validation platform, identify issues, and ensure compliance with cGMP guidelines and internal practices, defining standards and implementing them through KPIs.

You will develop, test and implement critical software applications that support the group, ensure change requests are tested and validated, promote continuous improvement, and maintain all validation

Qualifications

• University degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or equivalent.
• Experience in analytical chemistry and qualification & validation.
• Computer and mathematical logic knowledge.
• Written and oral English.
• Teamworking ability and proactive mindset.
• Accuracy and responsibility.

Responsibilities

• Set up and maintain CSV validation platform and ensure compliance with regulatory guidance.
• Develop, test and implement critical software applications that support the group.
• Ensure change requests are duly tested and validated per latest regulatory guidance and industry best practices.
• Promote a continuous improvement culture and mitigate unnecessary complexity.
• Maintain accurate validation documentation and related procedures (IOP, SOP, COP).
• Involvement in internal and external audits as required.
• Plan and deliver all assigned tasks on time, safely and cost-effectively.

Skills

Analytical chemistry

Qualification & validation

Computer knowledge

English (written and oral)

Teamwork

Accuracy

Education

University degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or equivalent

Tools

Empower

Job description

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, Marocco, Columbia and Brazil) with strong focus in expanding internationally and building strategic partnerships.

To strengthen our core team in Sintra (Lisboa), we are looking for a System Validation Specialist to join our company.

Your Mission:

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 and implementing through pre-defined KPIs at Tecnimede Group

Main responsibilities:

• Develop, test and implement critical software applications that support the group with support of Project Management;
• 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.
• 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;
• Written and oral English;
• Team working ability;
• 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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