Johann Strobl

Independent consultant for Quality management / Quality assurance. Providing solutions and support related to QM/QA topics and activities executed as a project or to support daily business. Area of activities: * GAP analysis * Quality Risk Management * Deviation, complaint, CAPA tracking * Release process * Document management * Supplier relationship management * Quality contracts

Qualification activities related to upgrade project of a facility for the manufacturing of biopharmaceutical API's

QA oversight of qualification activities related to a newly created laboratory building incl. HVAC, zoning, Isolator and autoclaves.

Qualification of the building and HVAC system, process equipment and validation of centralized SCADA system for a newly created biopharmaceutical API manufacturing plant.

Support the qualification of a newly created facility including utilities and process equipment for a Biopharmaceutical Drug Substance and Drug Product manufacturing site. In addition, support the site in updating the qualification / commissioning approach fitting the project scope.

Support the production team with regards to investigation & assessment of deviations occured during production processes as well as propose CAPA's for implementation.

Support implementation of Track & Trace functionality on the packaging lines including the Line Management System. Change Control, Deviation management and CAPA’s. Preparation and execution of qualification plan and reports.

Equipment Qualification (inspection & packaging lines), Line Mangement System Validation / Qualification, PLS Validation. Change Control / Deviation management, FAT / SAT execution, Qualification plan / report review. Creation of master templates for performance qualification templates. Creation / review of SOP’s

Establishing master templates and harmonization of qualification activities according internal and external regulatory requirements. Review and (Re-)qualification of manufacturing / inspection / packaging and other equipment (HVAC, autoclaves, IPC equipment). Change Control, deviation management and CAPA management related to the activities above.

Area of activities: * Equipment Qualification: creation, review and execution of (re-)qualification of equipment in sterile production, inspection, confection and laboratory) incl. HVAC, autoclaves, compound and filling lines. * Establishing master templates and harmonization of qualification activities according internal and external regulatory requirements. * Change control, deviation and CAPA management related to the activities above * Head Qualification Engineering ad interim:

Area: Global Quality Assurance Covering: Quality reporting of all Sandoz affiliates, Quality projects, Third Party Risk Assessement, Benchmarking/Scorecards, IT Project management

Global Quality Assurance - Technical Expert for * Supporting FDF Sites * Quality related project management * Benchmarking * Implementation of IT tools / IT Project management

Scope: Third Party Business (contracts, launches, compliance check, projects, complaints, release preparation) Own Sandoz sites (contracts, launches, projects, complaints, release preparation, allocation of QA responsibilities within Sandoz) Covering human / vet products.

Product Expert QA - own production cephalosporins

Laborant HPLC Analytik Qualitätssicherung

Ausbildung als Chemielaborant