BRUNO ANWEILER

Global Quality Process Manager, responsible for managing Veeva Quality Docs and Records Management for global Quality Assurance and ensuring compliance with cGxP and regulatory standards through continuous system updates. Key duties include developing and maintaining governance documents, to uphold quality standards across the organization. Additionally, leadership of the Global Process Stakeholder Forum fostered enhanced communication, collaboration, and process efficiency across teams

Supervising the Operations documentation department and managing aspects of the document lifecycle, including creation, change, approval, distribution, and archival. Supporting the Change Control system, acting as a change owner if necessary. Providing leadership, guidance, coaching, and ongoing personnel training and development. Building positive working relationships with different functional groups within the organization. Expert for the quality system in customer audits and authority inspections.

Managing audits and inspections, both internal and external, and leading inspection readiness activities for the operations deapartment. Conducting internal audits, compiling metrics, and evaluating trends for efficient monitoring of the quality system in terms of compliance. Additionally, Lead auditor during internal inspections, contributing to the overall compliance and quality assurance efforts of the organization.

Acting as a local Change Control Coordinator, overseeing local and global Change activities across various departments, scheduling and conducting Change Review Boards, and handling Change Control documents. Develop strategies to implement legal regulations and internal requirements for the specific QA System while ensuring compliance with Good Manufacturing Practices (GMP). Preparing for audits from regulatory authorities and customers. Creating SOP’s and Work Instructions.

Investigating exceptional events and complaints, encompassing root cause analysis, as well as the authoring, reviewing, and approval of Nonconformity reports, Laboratory Investigations, Planned Deviations, and Complaints. Planning and tracking of corrective and preventive actions, administering, and documenting related activities in TrackWise. Preparing for audits from regulatory authorities and customers.

Managing technical staff, including resource planning and coordination of maintenance and repair activities in Bulk Manufacturing & Melt Extrusion. Participation in projects for process and yield improvement. Main equipment responsibilities encompass various categories such as Granulation, Compression, Encapsulation, Filmcoating, Sorting, Tablet Printing, and Melt Extrusion, along with the Purified Water Plant. Create and approve SOP’s and work instructions, provide theoretical and practical staff training.

Supervising technical staff at shift level, entails resource planning and coordination of maintenance and repair activities in Bulk Manufacturing and Melt Extrusion as well as troubleshooting to ensure the quick and solid restoration of pharmaceutical production systems in these areas. Initiating and supporting continuous improvement initiatives regarding process and yield optimization. Creating and approving work instructions and theoretical as well as practical training of staff.

(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.

Responsible for the technical availability of pharmaceutical production equipment, including maintenance, repair, assembly, setup, and troubleshooting, specifically in the areas of bulk production and extrusion. Achievement: Due to outstanding performance promoted to Shift supervisor Mechanics.

Aircraft Maintenance Technician for the German Air Force (Bundeswehr/Luftwaffe) at Fighter Bomber Wing 33. Responsible for aircraft maintenance, inspections, safety, loading of weapons/ equipment, training of fresh staff at the ‘Tornado’ combat aircraft. Additionally, guarding military installations, and participating in international maneuvers. Achievement: Proposed and qualified as a crew rank for a career as a non-commissioned officer based on outstanding performance.

Vocational training & graduation to industrial mechanic's operating technology