Nathalie Kapps Email & Phone Number

Basel, Switzerland

QA Manager Basel Drug Substance ManufacturingWorking at Roche on behalf of ITech Consult

Kaiseraugst

- Project lead: In order to enable a better lead time adherence of the production charges, compilation of information from different IT systems for the calculation and visualisation of due dates for each process step- Definition of the requirements for the development of a Tableau dashboard for the visualisation and the monitoring of our Delivery KPI- Business Risk Management (BRM) & Business Continuity Management (BCM): -> Collection / consolidation of the business risks -> Creation / update of the BCM plans -> Adaption of the pandemie plan in collaboration with the business partners and the Site Risk & Business Continuity Manager- Coordination of the Workplace Health Risk Assessments: -> Creation of the occupational exposure assessments -> Preparation and moderation of the Security, Hygiene & Environment (SHE) inspection - Mental Health Wellbeing Advocate at Roche- Ergo Partner: support for a better ergonomics at workplace- Deputy for the project portfolio management

Kaiseraugst

- Project lead: Reduction of the sample volume for Follow-up Stability Studies (Savings: 420 kCHF per year)- Lead of the Data Integrity Initiative in the QC department, periodic presentation of the project status to the QC-leadership team and to the Senior Management- Pharmaceutical Quality System (PQS) Implementation -> Deputy / SPOC for the QC within the Site Implementation Team -> Process Implementation Manager or SME for several documents- Project lead and/or SPOC for the implementation of new global Requirements and training of the QC employees- Creation of changes in TrackWise- GMP inspections -> Representation of the QC in the Back Office -> Presentation of requests as SME -> Resolution of the QC wide findings- Change Agent for the class A certification and for the implementation of the Lean Production System (LPS) in the QC GMP Compliance Team- Continuous improvement processes- Moderation of the meetings for the continuous improvement of the QC KPIs

Kaiseraugst

- Leading a team of 7 to 11 employees- Project lead: -> Implementation of the PI Monitoring system for the new QC Building in Kaiseraugst -> Implementation of a new equipment database (Calibration Manager) -> Implementation of a new qualification concept- Key contributor for the development of the requalification concept regarding the relocation of the QC department from Basel to Kaiseraugst (Q2K project)- GMP Manager for the department- Training Manager

Basel Area, Switzerland

- Creation and update of the GMP master plan- Head of the GMP Team, coordination of GMP activities- Management of the qualification team- Execution of risks analysis (QuaSaR)- Creation of GMP documents (SOPs)- Training Manager, implementation of PharmSchul- ConDoR SuperUser: SPOC for the department, User assistance

Basel Area, Switzerland

- Management of an analytical team, deputy for the group leader- Responsible for the processing of complaints- Preparation of authority inspections- Creation of methods and SOPs- Creation and approval of product specifications in LIMS

Basel Area, Switzerland

Development and validation of analytical methods (HPLC, UV)

Interior Decoration

Master'S Degree, Industrial And Physical Pharmacy And Cosmetic Sciences, Dess Pharmacie Industrielle

Maitrise De Biochimie, Biochemistry

Licence De Biochimie, Biochemistry

Deug B (Biology), Biology, General

Dut Analyses Biologiques Et Biochimiques, Biology, General