Validation Specialist & QA Compliance – Software Validation - Dietzenbach, Germany - DEU 2022-004

Job Title

Validation Specialist & QA Compliance – Software Validation

Job Facts

Organizational Area
DACH
Country / State
Germany
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 2022-004

Job Scope

Your Mission

Ensure implementation of software, Excel spread sheets, qualified/validated equipment/processes.
Ensure monitoring of temperature control
Assisting with all quality assurance processes.

Main Responsibilities

Your Contributions
  • Execute process validations and qualifications in the production area
  • Execute Excel spreadsheet validations in the operations area
  • Execute smaller software validation projects (e.g. Codesoft for label creation)
  • Collaborate in software integration projects (e.g. upgrade and new implementation of inter-company tools)
  • Monitoring of automatic temperature control
  • Collaborate in deviation management (NC/CAPA & OOS management) for products and processes
  • Technical elimination of deviations (non-conformities)
  • Execute CAPAs
  • Administrative tasks in the Smart Solve Pilgrim system
  • Collaborate in change management (Change Control Management) for products and processes
  • Technical implementation of change requests (Request for Changes)
  • Administrative tasks in the Smart Solve Pilgrim System
  • Implement internal audits
  • Collaborate in risk management for processes
  • Collaborate in the area of Batch Record Review
  • Collaborate in projects and, if necessary, management of smaller projects

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

Several years of professional experience in the chemical industry or in the in-vitro diagnostics (IVD) industry in a comparable position (validation)

Technical Competencies
  • Experience in writing QM documents (according to ISO 13485, GMP, GLP, 21CFR820, or similar)
  • Validation of Excel spreadsheets and smaller software packages
  • Knowledge of statistical methods, such as Analyze-It or other statistical software skills desirable
  • High technical understanding and interest
  • Project and quality management experience
  • Very good command of MS Office
Skills
  • Strong organizational and conceptual thinking and acting skills
  • Strong ability to take personal responsibility, self-organize, prioritize and structure tasks and topics, a high degree of diligence and reliability, flexibility when priorities change
  • High level of social competence (written and oral communication skills, active listening, openness, cooperative working style, ability to work in a team and to take criticism,)
  • High willingness to take responsibility for own tasks
  • High willingness to work intensively on the success of the company as part of a 15-person team)
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