Validation Specialist & QA Compliance – Process Validation - Dietzenbach, Germany - DEU 2022-003

Job Title

Validation Specialist & QA Compliance – Process Validation

Job Facts

Organizational Area
DACH
Country / State
Germania
Place of work
Dietzenbach
Home/Office based
Office based

Professional Family: 

  • Operations
Reporting To
Team Leader Industrial & Validation Compliance

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
DEU 2022-003

Job Scope

Your Mission

Ensure the implementation of qualified/validated processes and equipment.
Ensure the monitoring of temperature control
Assist with all quality assurance processes

Main Responsibilities

Your Contributions
  • Plan and execute process validations and qualifications in Operations.
  • Supervise automatic temperature monitoring
  • Collaborate in the management of deviations (NCR/CAPA & OOS management) for products and processes
  • Responsible for the technical elimination of deviations (NCR) and for deriving and initiating measures
  • Carry out CAPAs and ensure the derived measures are implemented
  • Administrative tasks in the SmartSolve Pilgrim system
  • Collaborate in the change management process (Change Control Management) for products and processes
  • Technically implement change requests and change plans and ensure that the derived measures are implemented
  • Execute internal audits
  • Prepare and participate in national and international audits (GMED, FDA)
  • Collaborate in the organization of the quality management system
  • Collaborate in internal and interdepartmental projects
  • Take over special tasks on a case-by-case basis, if 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 BTA/CTA/MTA
Specialization
-
Experience
  • Experience in the in-vitro diagnostics (IVD) industry or in the chemical industry
  • Experience in the support of NC/CAPA/Change Control
  • Experience in writing QM documents (according to ISO 13485, GMP, GLP, 21CFR820, or similar)
Technical Competencies
  • Strong technical understanding and interest
  • Knowledge of immunoassays
  • Successful project and quality management experience
  • Knowledge of statistical analysis
  • Good knowledge of MS Office
Skills
  • Strong organizational and conceptual thinking and acting skills
  • Strong ability to self-organize, prioritize and structure tasks and topics and a high degree of diligence and reliability
  • Strong interpersonal skills (written and verbal communication skills, active listening, openness, cooperative work style, ability to work in a team, and critical thinking 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

Initial training program

Benefits

We Offer You

As per local and Company requirements