CSV Validation Specialist for GMP Software Quality

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 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