Job Title
Validation Specialist & QA Compliance – Process Validation
Job Facts
Legal Entity
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 2022-003
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