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

- 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

- 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

- 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

- 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

- 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

Development and validation of analytical methods (HPLC, UV)