Quality Assurance Technician

Overview:

Our client is seeking a meticulous and proactive Quality Assurance Technician to provide administrative and technical support to the Quality Assurance team, with a focus on qualification and validation activities. This role requires a strong understanding of quality systems and an ability to work collaboratively in a regulated environment.

Key Responsibilities:

• Develop qualification, validation, and computer system validation documents in both English and German.
• Draft, revise, and review SOPs, work instructions, and forms.
• Conduct qualification and validation activities for equipment, systems, and processes.
• Perform temperature distribution measurements and evaluate and verify related documentation.
• Participate in the preparation of risk analyses to support validation processes.
• Maintain qualification/quality system records, including lists, folder structures, and logbooks.
• Manage qualification test equipment and ensure its proper use.
• Communicate and resolve quality-related issues in compliance with European GMP guidelines.
• Assist in coordinating and reviewing deviations, CAPAs, and final report preparation.
• Support the change control process, ensuring timely completion of actions by respective owners.
• Contribute to the preparation of monthly quality metrics and other reports as needed.

Qualifications and Experience:

• Completed vocational training or a bachelor’s degree in pharmaceutical, scientific, or technical fields.
• Proficiency in MS Office tools, including Excel, Word, and Outlook.
• Good written and spoken skills in German and/or English.
• Knowledge of GMP guidelines or comparable regulations is an advantage.

Skills:

• Attention to detail and strong organizational abilities.
• Ability to work collaboratively across departments.
• Analytical mindset with problem-solving skills.
• Proactive approach to tasks and ability to adapt to dynamic business demands.