QA Documentation Engineer

QCS Staffing; Frankfurt; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

A global leader in life sciences is looking for a QA Documentation Engineer for a 12-month contract in Frankfurt, Germany. This role involves implementing document control processes, supporting CQV documentation, and ensuring compliance with regulatory standards. The ideal candidate will have a degree in a relevant field and experience within a GMP-regulated environment. This position offers a unique opportunity to be part of impactful projects in advanced manufacturing.

Qualifikationen

• Degree in Life Sciences, Engineering, Quality, or related discipline.
• Experience in a GMP-regulated biotech, pharmaceutical, or medical device environment.
• Strong understanding of GDocP, data integrity, and regulatory expectations for documentation.
• Hands-on experience with document control systems.

Aufgaben

• Implement and maintain document control processes aligned with GMP.
• Support the development and execution of commissioning, qualification, and validation documentation.
• Ensure documentation practices comply with GxP and internal quality standards.
• Train project and operational staff on documentation standards.

Kenntnisse

Document control processes

Training on documentation standards

Understanding of GDocP

Data integrity

ALCOA

Regulatory compliance

Staff training

Ausbildung

Degree in Life Sciences, Engineering, Quality, or related discipline

Engineering

Quality discipline

Tools

Veeva Vault

Kneat

Eida Track Wise

Jobbeschreibung

Overview

QA Documentation Engineer - Germany, Frankfurt - 12 Months Initial Contract. Looking to take your career to the next level? We’re recruiting for a high-impact pharmaceutical project located near Frankfurt. With major capital investment experience driving various facility build projects. This is a unique opportunity for a QA Documentation Engineer to join a global leader in the life sciences market and play a key role in shaping the future of advanced manufacturing.

What You’ll Do

• Implement, and maintain document control processes aligned with GMP, GDocP, and project requirements.


• Support the development and execution of commissioning, qualification, and validation (CQV) documentation.


• Ensure documentation practices comply with GxP, data integrity (ALCOA ), and internal quality standards.


• Train project and operational staff on documentation standards, templates, and systems.

What you’ll need

• Degree in Life Sciences, Engineering, Quality, or related discipline.


• Experience in a GMP-regulated biotech, pharmaceutical, or medical device environment.


• Strong understanding of GDocP, data integrity, and regulatory expectations for documentation.


• Hands-on experience with document control systems (e.g., Veeva Vault, Kneat, Eida Track Wise,).

Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!