Bizjar Fattah
Sinsheim
Summary
Effective motivator, optimist and people-oriented leader with 5+ years work experience in the diagnostics field with in-depth knowledge of several product portfolios (BGE/Urinalysis). Seeking to gather more people leader experience with developing personal leading skills in harmony with the Roche leading principles. Dedicated Team Leader with expertise in quality assurance initiatives, issue resolution and interpersonal communication. Proficient with project management, personnel training and production scheduling. Sets example for work ethic, punctuality and quality.
Overview
6
6
years of professional experience
Work History
Team Lead On-Market Support
Roche Diagnostics GmbH
Mannheim
01.2024 - 01.2025
- Company Overview: Department System Development and Integration
- Leading and developing a team of 8 direct reports (technical project lead, lab staff, development lead) as part of the On-Market sub-chapter.
- Responsibility of three labs for occupational safety, environmental protection and quality assurance.
- Product Owner in agile Framework for optical systems (Urinalysis PoC and Core Lab Portfolio).
- Standardization and optimization of working structures in line with the MQMS D&D Module as part of continuous improvement.
- Planning and coordination of a laboratory relocation.
- Department System Development and Integration
Ad-Interim Team Lead
Roche Diagnostics GmbH
Mannheim
07.2023 - 08.2024
- Company Overview: Department Assay Development BGE and Continuous Monitoring
- Team leader of a team of 4 employees, with all accompanying responsibilities (resource planning, employee check-ups, team jour fixes) during IVDR Project.
- Department Assay Development BGE and Continuous Monitoring
Product Responsible Person BGE On-Market
Roche Diagnostics GmbH
Mannheim
01.2023 - 01.2024
- Company Overview: Department Assay Development BGE and Continuous Monitoring
- Maintaining of product documentation compliance during life cycle.
- Product care activities (risk management, requirements management, usability, 3rd level complaint handling support, regulatory driven documentation updates, design history file updates and ownership).
- Expert know-how of the systems including all its components and consumables.
- R&D Representative in cross-functional meetings in case of Safety boards/Impact Assessment meetings.
- R&D Representative in Audits for owned NC/CAPAs.
- Supporting function as R&D Representative in alignments regarding roadmaps, improvements, timelines.
- Project Lead IVDR and smaller projects.
- Department Assay Development BGE and Continuous Monitoring
Chemical engineer
Roche Diagnostics GmbH
Mannheim
01.2019 - 01.2023
- Company Overview: Department Assay Development BGE and Continuous Monitoring
- Ensurance of project progress by planning of necessary meetings and tracking of upcoming tasks within the IVDR (In-Vitro Diagnostic Regulations) compliance project for the Roche 9180 Electrolyte Analyzer.
- Active participation in cross-interface meetings with different departments in Rotkreuz (Regulatory, Quality Assurance, Clinical Science, Operations, Medical and Scientific Affairs).
- Planning and execution of internal verification and validation activities.
- Writing of Test plans and reports.
- Evaluation and interpretation of study results with different tools.
- Lab activity coordination and documentation.
- Creation of DCC/compliance documents on system level.
- Creation of Product Specification documents with accompanying Change Requests and Impact Assessments.
- Department Assay Development BGE and Continuous Monitoring
Education
Master - Biomedical Science and Technology
University of applied sciences Mannheim
01.2019
Bachelor - Biotechnology
University of applied sciences Mannheim
01.2018
Skills
- IT knowledge
- Microsoft office
- SAP
- DiaDoc
- HP-ALM (Requirement engineer)
- Photoshop
- Image J
- Zeiss ZEN
- Basics #R
- OASE Pro
Personal Information
- Date of Birth: 02/16/91
- Nationality: Dutch
- Driving License: Category B
Languages
- Kurdish, native
- Dutch, excellent
- English, excellent
- German, excellent
Hobbies and Interests
- Reading
- Blog (bizjarfattah@blogspot.com)
- Travelling
- Cooking
- Gardening
- Running
- Family and Friends
Insights
- RoHS
- EHS
- CLSI
- IVDD/IVDR
- CE mark
- Labeling
- Complaint handling
- Regulatory requests
- Compliance (process, design)
- SHE
Certifications And Personal Development
- Certified SAFe 6 Agilist
- PM Competence Project management
- Leadership Excellence Program (Agile working, VACC)
Timeline
Team Lead On-Market Support
Roche Diagnostics GmbH
01.2024 - 01.2025
Ad-Interim Team Lead
Roche Diagnostics GmbH
07.2023 - 08.2024
Product Responsible Person BGE On-Market
Roche Diagnostics GmbH
01.2023 - 01.2024
Chemical engineer
Roche Diagnostics GmbH
01.2019 - 01.2023
Master - Biomedical Science and Technology
University of applied sciences Mannheim
Bachelor - Biotechnology
University of applied sciences Mannheim
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