2018 - 2020: Logistics managementRole: Logistics Manager
Customer: DIATAKAM, Essoffe
Tasks:Volunteer in several non-governmental organizations that care for orphans and war victims in Africa.
07/2018 ? 10/2018: Medicals Affairs and Pharmacovigilance SystemsRole: Applications Manager
Customer: Ext. Bayer Business Services GmbH, Berlin
Tasks:- PV (Oracle Argus) Launcher ?Applications Manager
- Responsible for managing the operational support.
- Identity and Access Management
- Maintenance and development activities for the application.
- Responsible for appropriate staffing, staff management, performance management and continuous service improvement
- LSH (Oracle Life Sciences Data Hub) Rave Adapter Enhancement Project ? Validation Lead
- As QA I was involved in all validation activities
- Took a lead in performing the vendor assessment and verified that all validation activities and documents complied with applicable regulations and internal procedures.
- Reviewed and approved validation documents such as requirement specifications, test plans, summary test results and final validation reports.
- ?Reviewed and approved Standard Operating Procedure.
- Consulting in implementation of regulations
- Compliance with regulations is guaranteed.
- Consulting in the planning and implementation of processes or technical solutions in regulate business functions R&D, Medical Affairs and Pharmacovigilance
- Increase efficiency by automating R&D processes.
- Support in technical Change Management
02/2018 - 03/2018: General Data Protection Regulation (GDPR)Customer: Hoffmann-La Roche Basel
Tasks:- Project Support
- Document Management System
2015 ? 2017:
IT Quality and IT SecurityRole: IT Quality and IT Security Specialist
Customer: Hoffmann-La Roche Basel
Tasks:- Identified and notified owners of outdated operating systems to reduce the risk of unpatched and vulnerable systems.
- Worked with HP Service Managers-HPSM- in Change and Incident Management to handle IT security related incidents, manage team HPSM queue and request changes to improve the security posture of Roche systems.
- Ensured that all Roche Windows computers have security tools operating appropriately by creating reports on non-compliant activity and following up with appropriate service desks protection for these critical systems.
- Conduct a systematic monthly review of critical IT authentication systems to ensure compliance with minimum security baselines, resulting in improved security protection for these critical systems.
2007 ? 2015: IT ProjectsRole: Quality Analyst (CSV)
Customer: Roche Diagnostics GmbH, Mannheim (Germany)
Tasks:- Provided Quality Support and Quality Consultation to global or local IT Projects, acted as the single point of Q-support, as a project team member
- Ensured internal and external standards are met, ensured regulatory compliance is met.
- Ensured good documentation practices are followed, reviewed along checklists, keep the checklists themselves up to date, created revisions of those checklists together with peers.
- Created life cycle documents according to project methodology, ensured life cycle documents are reviewed and approved and current templates are used.
- Review and approval of test documents in HPALM
- CAPA Support
- Review and Approval of URS, FAT, SAT, DG, IQ, OQ, PQ
- Change Management
- Workflow Management
- GxP Assessment in CMDB
- System Risk Assessment
- If needed, adequate tailoring of project deliverables is recommended and made
- Non-compliance, jeopardizing quality and regulatory, are escaladed appropriately
- Training in documentation, good documentation practices, templates etc. delivered, as required by project teams
- Provide QA support for topics related to computerized systems, Process validation and equipment qualification
- IT-System Maintenance and ongoing compliance is supported in reviewing changes and approving changes, those reviews follow special dedicated checklists established within peer group
- System Maintenance is supported by monitoring IT Quality Service request inbox and by acting on those service requests
- The IT Quality internal processes are observed and evaluated, and improvement ideas are made to the line manager
- Deviation Management
- Special Quality tasks, remediation activities, internal initiatives are supported, contribution are made to improve the IT-Q services
- In a global Quality Service team, the right information flow and experience exchange happens, contributions to global meetings across different time zones are made
2003 - 2007: Changes Review and Approval in HPSMRole: Quality Analyst (CSV)
Customer: Roche Diagnostics GmbH, Mannheim (Germany)
Tasks:- Changes Review and Approval in HPSM
- Support the implementation of GxP and non GxP IT infrastructure and computerized systems.
- Review and approval of QMS related records and documents
- Support data integrity implementation and remediation of GxP systems
- Periodic review of assigned systems.
- Support all global quality initiatives including data integrity, computerized systems, and IT QMS implementation.
- Projects Support as Quality Analyst
- Review and Approval of
- DQ, FAT, SAT, IQ, OQ, PQ in Document Management System
- Technical Documents in Clarify
- Test Document
- computer system documentation, such as risk analysis, user requirement specifications, validation and verification report, traceability reports, change request.
- Maintaining the Validation Master Plan
- Single point of contact representing Quality Assurance within the defined validation and qualification Projects
- Training and educating the project team for good documentation practice.
- Provide QA support for topics related to computerized systems, Process validation and equipment qualification.
- Deviation investigation
- CAPA Support
- System Risk Assessment
2002 - 2003: variousRole: Programmer
Customer: Roche Diagnostics GmbH, Mannheim (Germany)
Tasks:- Program developer
- Reviewing, current systems
- Presenting ideas for systems improvement.
- Working closely with analysts, designers, and staff.
- Producing details specifications and writing the program codes
- Testing the product in controlled, and real situation before going live.
- Preparation of training manuals for users.
- Maintaining the systems once they are up and running.
2000 - 2002: SAP P86 Rollout Project Support Role: SAP R/3 Developer
Customer: Roche Diagnostics GmbH, Mannheim (Germany)
Tasks:- SAP P86 Rollout Project Support
- Customizing
- Validation Registry Administration
- ABAP
1995 - 2000: Order ProcessingCustomer: Roche Diagnostics GmbH, Mannheim (Germany)
Tasks:- Order Processing, Purchasing
- Submission of a Purchase Order
- ?Purchase Order Processing