Quality Assurance Specialist (DHR & Calibration Coordinator) - Dietzenbach, Germany - DEU 2022-002

Job Title

Quality Assurance Specialist (DHR & Calibration Coordinator)

Job Facts

Organizational Area
Country / State
Place of work
Home/Office based
Office based

Professional Family: 

  • Operations
Reporting To
Team Leader Doc and QMS

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Job ID
DEU 2022-002

Job Scope

Your Mission

Ensure QA compliance,
Maintain QM system (performing Batch Record Review for final market release of batches of DSD products, coordinating processes from Calibration & Maintenance)

Main Responsibilities

Your Contributions
  • Perform batch record reviews (review of batch documentation from production and quality control or device history records).
  • Inform Production and Quality Control departments about non GMP compliant documentation.
  • Coordinate "Calibration & Maintenance" processes and support QM documentation departments.
  • Maintenance of GMP compliance.
  • Revision of SOPs and creation of forms, especially in the area of maintenance and calibration.
  • Close cooperation with the "Change Control" and "Non-Conformity/CAPA" teams within the Quality Assurance department
  • Collaborate in organizing the quality management system in general
  • Carry out GMP training courses
  • Archive GMP-relevant documentation in the OPS area
  • Export parts lists from SAP for technical documentation
  • Further/other tasks which are reasonable within the scope of the qualification

Qualifications Experience Personal Strengths Mobility

Completed scientific education, preferably in the field of biochemistry, biology, chemistry or similar - Diploma-/Master-/Bachelor-level or experienced TA
  • Experience in quality control, manufacturing or quality management
  • Several years of experience with GMP-compliant working methods
  • Experience in writing QM documents (according to ISO 13485, GMP, GLP, 21CFR820, or similar)
Technical Competencies
  • Technical understanding
  • Basic immunological knowledge
  • Knowledge of immunoassays and database experience
  • Good knowledge of MS Office (especially Excel and Word) and profound knowledge of Lotus Notes and SAP
  • Ability to self-organize, prioritize and work in a structured manner
  • Organizational and conceptual thinking skills
  • High degree of diligence and reliability
  • High level of social competence (good communication skills, active listening, openness, cooperative working style and strong teamwork skills)
- Fluent German (spoken and written) - Very good English (written and spoken)
Travel Availability
No as a routine part of the job
Relocation Availability
Training Required

Intial training program


We Offer You

As per local and Company requirements