BRUNO ANWEILER

• Manage Veeva Quality Docs and Records for global Quality Assurance, ensuring compliance with cGxP and regulatory requirements. • Oversee governance documents, lead the Community of Practice (CoP), and deliver training to support quality processes. • Serve as Quality System Lead for Veeva Quality Docs and Records, supporting deviation management and audits. • Contribute to QA-IT system changes and engage with industry groups to drive process improvements.

• Led the Operations documentation department, managing the full document lifecycle from creation to archival. • Supported the Change Control system and acted as change owner when required. • Provided leadership, coaching, and ongoing training for personnel while fostering collaboration with crossfunctional teams. • Acted as quality system expert during customer audits and regulatory inspections.

• Managed internal and external audits and inspections, leading inspection readiness activities. • Conducted internal audits, compiled metrics, and evaluated trends to monitor quality system compliance. • Served as lead auditor during internal inspections; planned and tracked corrective and preventive actions in TrackWise.

• Planned and conducted Change Review Boards; processed change requests at local and global levels in collaboration with relevant departments. • Managed documentation and monitoring of associated activities in TrackWise. • Developed strategies to implement legal and internal requirements, ensuring GMP compliance. • Created and revised work instructions and supported preparation for regulatory inspections and customer audits.

• Investigated exceptional events and complaints, including root cause analysis and documentation of nonconformities, laboratory investigations, planned deviations, and complaints. • Managed CAPAs and related activities in TrackWise; prepared for audits by regulatory authorities and customers.

• Managed technical staff and coordinated maintenance and repair activities in Bulk Manufacturing and Melt Extrusion. • Participated in process and yield improvement projects across granulation, compression, encapsulation and Melt Extrusion. • Developed and revised maintenance procedures and conducted staff training.

• Supervised technical staff on shift, coordinated maintenance and repair activities, and ensured rapid troubleshooting of production systems. • Supported continuous improvement initiatives and developed work instructions and training programs.

(Englisch translation below) Erfolgreicher Abschluss der Berufsbegleitenden Weiterbildung zum Industriemeister Fachrichtung Metall (IHK), sowie Erwerb des arbeitspädagogischen Nachweis für die Ausbildung von Auszubildenden. Successful completion of the part-time education programm to become an Bachelor Professional of Metal Production, Technology and Operation (CCI), as well as acquisition of the occupational pedagogical certificate for the training of trainees.

• Maintained and repaired pharmaceutical production equipment, including setup, troubleshooting, and assembly, particularly in bulk production and extrusion areas.

• Served as Aircraft Maintenance Technician at Fighter Bomber Wing 33, responsible for inspections, safety checks, and maintenance of Tornado combat aircraft. • Trained new personnel, managed weapons and equipment loading, and participated in international military exercises.

Vocational training & graduation to industrial mechanic's operating technology