Quality Assurance Manager (m/f/d)

ProtaGene US, Inc; Dortmund; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Benefits dieser Stelle

Development opportunities

Advanced personnel development concept

Health management

JobRad leasing

Zusammenfassung

ProtaGene US, Inc in Dortmund is seeking a Quality Manager to oversee quality management systems, prepare QM documents, and manage compliance with regulatory audits.

The ideal candidate will have a degree in pharmacy or natural sciences and at least 3 years’ experience in a regulated pharmaceutical environment. Proficiency in both German and English is essential.

Join a dynamic and supportive working culture with development opportunities in our innovative international team.

Qualifikationen

• Successfully completed degree in pharmacy or natural sciences, or relevant vocational qualification.
• At least 3 years of professional experience in a regulated pharmaceutical environment.
• Solid knowledge and experience in quality management under GMP conditions.
• Confident in working with computer-based systems and very good German and English language skills.

Aufgaben

• Maintenance and continuous improvement of the quality management system.
• Preparation, review, and management of QM documents.
• Processing, evaluation, and tracking of deviations, changes, and CAPA processes.
• Planning, monitoring, and execution of training activities.
• Review of analytical tests and preparation of audits.

Kenntnisse

Quality management

Analytical testing

GMP conditions

German language proficiency

English language proficiency

Ausbildung

Degree in pharmacy or natural sciences

Jobbeschreibung

Maintenance and continuous improvement of the quality management system

Preparation, review, and management of QM documents

Processing, evaluation, and tracking of deviations, changes, and CAPA processes

Planning, monitoring, and execution of training activities

Planning and monitoring of qualification and validation activities

Review of analytical tests

Preparation and conduct of customer and regulatory audits as well as self-inspections

Job requirements

Successfully completed degree in pharmacy or natural sciences, or a relevant vocational qualification with at least 3 years of professional experience in a regulated pharmaceutical environment

Solid knowledge and professional experience in quality management under GMP conditions

High level of quality awareness, process orientation, accuracy, reliability, flexibility, and goal-oriented working style

Focused and thorough working approach with attention to both detail and the overall process

Willingness to take responsibility for assigned processes and to pursue defined goals in a committed and focused manner

Team-oriented mindset and enjoyment of active communication with colleagues and customers

Confident in working with computer-based systems and very good German and English language skills

We offer

A dynamic and challenging working environment in an independent, innovative international corporate group with currently approx. 175 employees, headquartered in Germany

Development opportunities in a central role and in a growing organization

An open, professional, and collegial working culture that is appreciative of values and contributions

An advanced personnel development concept including regular employee/feedback discussions, health management, JobRad leasing