André Silveira

Berufserfahrung von André Silveira

• Bis heute 1 Jahr und 6 Monate, seit Dez. 2022

  Technical Compliance (TC-CSV) - Project Consultant

  Sanofi-Aventis Deutschland GmbH

  - Preparing and representing during internal and external inspections in the field of qualification and validation of computerized systems. - Processing and expert evaluation of CC and CAPAs. - Creation of and participation in the compilation of qualification/ validation documentation in compliance with internal requirements as well as legal and regulatory guidelines - Implementation and monitoring of GMP-compliant processing of qualification measures / validation - Project planning and management

• 7 Monate, Mai 2022 - Nov. 2022

  QA Manager with emphasis on IT Systems / Data Integrity

  Merck Group

  - Support in ensuring GMP requirements related to computerized laboratory systems and data management. - Supporting the departments in the implementation of data integrity (ALCOA principles) for new acquisitions and for existing systems, including risk analyses - Support the planning and execution of computer system validations (CSV), as well as requalifications as part of changes - Training of employees in the area of data integrity - Creation and review of SOPs and other documents for GMP compliance

• 1 Jahr und 11 Monate, Juli 2020 - Mai 2022

  QA-CSV Expert

  Sanofi-Aventis Deutschland GmbH

  - Execution of validations of computerized systems together with the nominated system owner - Implementation of annual system reviews to assess and ensure the validation status of computerized systems - Coordination and evaluation of deviation reports and change control processes on existing IT systems in the GMP environment - Support during inspections, audits etc. with regard to the IT systems in use - Creation of standard operating procedures (SOPs) - Excel/Access/Script Validations

• 1 Jahr und 7 Monate, Okt. 2018 - Apr. 2020

  Qualification/ Validation Consultant

  PQE Group

  Validation of computerized systems in pharmaceutical companies Qualification of machines and equipment Risk analysis Preparation/checking of GMP documents SOPs and procedural instructions