Quality Assurance Engineer

Katalyst CRO; Emmendingen (Kernstadt); On-site; EUR 70,000 - 90,000; Full time

Job summary

Katalyst CRO in Germany is seeking a QA Engineer with Life Sciences domain experience to support testing and validation in a regulated environment. You will develop and execute manual and automated tests, ensuring compliance with GxP and FDA-21 CFR Part 11, while collaborating with cross-functional Agile teams.

The role requires 10+ years in QA, hands-on with Selenium, and experience with JIRA. Based in Baden-Württemberg, Emmendingen, the position is on-site and integral to ensuring quality in

Qualifications

• 10+ years of QA/testing experience.
• Experience in Life Sciences / Pharma domain.
• Strong knowledge of GxP and FDA regulations.
• Hands-on with Selenium or other automation tools.
• Experience with JIRA or similar tools.

Responsibilities

• Develop and execute manual and automation test cases.
• Perform functional, regression, and integration testing.
• Log and track defects using JIRA or similar tools.
• Ensure compliance with GxP, FDA, and 21 CFR Part 11 regulations.
• Collaborate with cross-functional teams in an Agile environment.

Skills

QA Engineer

Life Sciences

Automation testing

JIRA

Agile

Tools

Selenium

Job description

Job Description

We are looking for a QA Engineer with Life Sciences domain experience to support testing and validation in a regulated environment.

Responsibilities

• Develop & execute manual and automation test cases.
• Perform functional, regression, and integration testing.
• Log and track defects using JIRA or similar tools.
• Ensure compliance with GxP, FDA, and 21 CFR Part 11 regulations.
• Collaborate with cross-functional teams in an Agile environment.

Requirements

• 10+ years of experience in QA / Testing.
• Experience in Life Sciences / Pharma domain.
• Strong knowledge of GxP, FDA regulations.
• Hands-on with Selenium or automation tools.
• Experience with JIRA or similar tools.

Nice to Have

• CSV (Computer System Validation) experience.
• API Testing (Postman). Basic SQL knowledge.