Skill-Profil eines fest angestellten Mitarbeiters des Dienstleisters
Einsatzorte
Einsatzorte
Deutschland, Schweiz, Österreich
möglich
Projekte
Projekte
1 year 7 months
2024-06 - 2025-12
Global LIMS Implementation (Labware 8)
Consultant: Validation Lead
Consultant: Validation Lead
? Responsible for all validation activities for a global LIMS implementation (Labware 8).
Concepting integration and validation of interface strategy.
Ensuring Annex 11 and 21 CFR part21 compliance.
Creation of migration plan from Labware 5 to Labware 8 for the site.
Creation of Master Data Verification System and Life Cycle Management for Labware 8 LIMS Go-Live.
Aligning and mapping Master Data Sets for migration
Interface Validation to SAP, MODA, OMNIS, Chromelion
Creation and implementation of Transition plan for the site.
Working and reporting in an international project setup.
Ensuring laboratory process readiness based on updated LIMS.
Organizational Change Management for the Site Singen.
SAPMODAOMNISChromelionLabware 8 LIMS
Takeda GmbH
Remote
2 years 9 months
2021-10 - 2024-06
Development and implementation of a global LIMS (LabWare 8)
Consultant: Organizational Change Manager
Consultant: Organizational Change Manager
Process development and implementation of a global LIMS (LabWare 8) solution in collaboration with developers, laboratories, production, global teams, management, and site leaders.
Global BioNTech support for all Q-System deployment strategies.
SAP S/4HANA Interfacing and validation support.
Harmonization of IT and quality procedures between sites.
Conducting GAP assessments and required actions for computerized systems in accordance with FDA CFR21 Part11 and EU GMP Annex 11.
Supporting computer system validation based on GAMP5 requirements.
Creation of validation documentation and technical specifications.
Assisting the global corporate transition into digital process landscapes and global Q-process harmonizations.
Defining and integrating site-specific Quality Process Owners.
Implementing digital Quality Units at new locations and integrating Application Life Cycle Management.
Global Master Data Management project management support and life cycle management setup.
Project management for the harmonization of global laboratory and production procedures.
Development of Service Level Agreements between departments.
Creation and management of a training system for the introduction of a global LIMS with a focus on GMP and GLP.
S/4HANALabware 8 LIMS
BioNTech Europe GmbH
Remote
1 year 10 months
2019-07 - 2021-04
Coordinator and Project Manager for the commissioning of Biotest's new production building Next Level (plasma fractionation)
Consultant: Facility Commissioning Officer
Consultant: Facility Commissioning Officer
Coordinator and Project Manager for the commissioning of Biotest's new production building Next Level (plasma fractionation).
Ensuring German and FDA Audit Readiness for the entire program.
Establishment of a Compliance Learning Management System for the new BNL production building in consultation with the responsible departments.
SAP process updates and validation support.
Harmonizing and implementing procedures and validation approaches for the new infrastructure in collaboration with Head of Quality.
Compliance check of all document modifications.
Compliance check of all method modifications.
Review and evaluation of laboratory reports.
Coordination between production, laboratories, logistics, and all subteams.
Planning and management of sample panels in consultation with CMC and development.
Data Integrity evaluation of the new processes, associated master data, and transfer processes.
GAP assessments, risk assessments, CSV evaluations.
Preparation of training materials and conducting training sessions.
Cleanroom monitoring optimization project to reduce contamination risks.
SAP QM
Biotest AG
Hybrid
Kompetenzen
Kompetenzen
Qualitätssicherung
Computer System Validation
Experte
Labware 8 LIMS Implementation
Experte
Organisational Change Management
Experte
Einsatzorte
Einsatzorte
Deutschland, Schweiz, Österreich
möglich
Projekte
Projekte
1 year 7 months
2024-06 - 2025-12
Global LIMS Implementation (Labware 8)
Consultant: Validation Lead
Consultant: Validation Lead
? Responsible for all validation activities for a global LIMS implementation (Labware 8).
Concepting integration and validation of interface strategy.
Ensuring Annex 11 and 21 CFR part21 compliance.
Creation of migration plan from Labware 5 to Labware 8 for the site.
Creation of Master Data Verification System and Life Cycle Management for Labware 8 LIMS Go-Live.
Aligning and mapping Master Data Sets for migration
Interface Validation to SAP, MODA, OMNIS, Chromelion
Creation and implementation of Transition plan for the site.
Working and reporting in an international project setup.
Ensuring laboratory process readiness based on updated LIMS.
Organizational Change Management for the Site Singen.
SAPMODAOMNISChromelionLabware 8 LIMS
Takeda GmbH
Remote
2 years 9 months
2021-10 - 2024-06
Development and implementation of a global LIMS (LabWare 8)
Consultant: Organizational Change Manager
Consultant: Organizational Change Manager
Process development and implementation of a global LIMS (LabWare 8) solution in collaboration with developers, laboratories, production, global teams, management, and site leaders.
Global BioNTech support for all Q-System deployment strategies.
SAP S/4HANA Interfacing and validation support.
Harmonization of IT and quality procedures between sites.
Conducting GAP assessments and required actions for computerized systems in accordance with FDA CFR21 Part11 and EU GMP Annex 11.
Supporting computer system validation based on GAMP5 requirements.
Creation of validation documentation and technical specifications.
Assisting the global corporate transition into digital process landscapes and global Q-process harmonizations.
Defining and integrating site-specific Quality Process Owners.
Implementing digital Quality Units at new locations and integrating Application Life Cycle Management.
Global Master Data Management project management support and life cycle management setup.
Project management for the harmonization of global laboratory and production procedures.
Development of Service Level Agreements between departments.
Creation and management of a training system for the introduction of a global LIMS with a focus on GMP and GLP.
S/4HANALabware 8 LIMS
BioNTech Europe GmbH
Remote
1 year 10 months
2019-07 - 2021-04
Coordinator and Project Manager for the commissioning of Biotest's new production building Next Level (plasma fractionation)
Consultant: Facility Commissioning Officer
Consultant: Facility Commissioning Officer
Coordinator and Project Manager for the commissioning of Biotest's new production building Next Level (plasma fractionation).
Ensuring German and FDA Audit Readiness for the entire program.
Establishment of a Compliance Learning Management System for the new BNL production building in consultation with the responsible departments.
SAP process updates and validation support.
Harmonizing and implementing procedures and validation approaches for the new infrastructure in collaboration with Head of Quality.
Compliance check of all document modifications.
Compliance check of all method modifications.
Review and evaluation of laboratory reports.
Coordination between production, laboratories, logistics, and all subteams.
Planning and management of sample panels in consultation with CMC and development.
Data Integrity evaluation of the new processes, associated master data, and transfer processes.
GAP assessments, risk assessments, CSV evaluations.
Preparation of training materials and conducting training sessions.
Cleanroom monitoring optimization project to reduce contamination risks.
SAP QM
Biotest AG
Hybrid
Kompetenzen
Kompetenzen
Qualitätssicherung
Computer System Validation
Experte
Labware 8 LIMS Implementation
Experte
Organisational Change Management
Experte
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