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

Job Title

Quality Assurance Specialist (DHR & Calibration Coordinator)

Job Facts

Organizational Area
DACH
Country / State
Germania
Place of work
Dietzenbach
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
Permanent
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

You
Education
Completed scientific education, preferably in the field of biochemistry, biology, chemistry or similar - Diploma-/Master-/Bachelor-level or experienced TA
Specialization
-
Experience
  • 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
Skills
  • 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)
Languages
- Fluent German (spoken and written) - Very good English (written and spoken)
Travel Availability
No as a routine part of the job
Relocation Availability
No
Training Required

Intial training program

Benefits

We Offer You

As per local and Company requirements