Unterlangkampfen, Tyrol, Austria
Senior professional in the pharmaceutical development and manufacturing of oral forms and biological products. Proven ability to work effectively in international teams. Passionate about environmental sustainability and keen on living outside his comfort zone.
Lead and manage technology transfers of Drug Product manufacturing processes from Lab / Pilot scale to clinical and commercial manufacturing sites (Novartis and external CMO's).
Project Team Lead for the Decommissioning of site wide Quality Control Laboratories with management of cross-functional teams, from the development of the Laboratory Equipment Decommissioning Plan to the creation and management of Change Controls that would fulfill QA, HSE and business requirements. Responsible of Decommissioning schedule and project progress; Periodic reporting to Site Leadership Team.
Formulation, Filling and Packaging of vaccine syringes. Team Lead of four Production Improvement Projects (business cases created during a 3-day Mistake Proof Workshop); Investigational Excellence certification; Gemba Program Champion in Secondary Manufacturing (5S Program, Visual Management, Leadership Gemba walks on the shop floor); Owner of Deviation Reports (DRs), Corrective Actions Preventive Actions (CAPAs) and Change Controls (CCs); Batch Production Records (BPRs) and Standard Operational Procedures (SOPs) update; Support to Validation activities; Subject Matter Expert (SME) for Secondary DRs and CCs during Food and Drug Administration (FDA) Pre-Approval Inspection.
Manufacturing and Packaging of solid dosage forms. Formal delegate of the Process Unit Head (Leadership Team); Responsible for management of operational teams; setting of PU Objectives and KPI’s and continuous monitoring/follow up; support PU Head in planning strategic activities for the achievement of the PU Objectives; Supervisor of the overall performance of shop floor personnel; support PU Head in solving and improving all processes within the PU; Budgeting process and review with Finance Department; Development Coach in the shop floor Peer Review Process; Production Batch Record Approver.
Manufacturing and Packaging of solid dosage forms. Creation, review and update of Master Batch Records; Production associates Annual Training Plan; SOP’s update and Lead trainer for Process Unit Voltaren /Pursennid; Subject Matter Expert (SME) on Production-related SOP’s during internal and external audits; Change Control management, Deviation Investigator; QA Support and Supervisor on the shop-floor; Production Batch Record QA Approver.
Manufacturing and Packaging of solid dosage forms. Short-term international assignment as Process Deviation Investigator to support the reduction of deviations backlog. Deviation investigation Reports reviewed and approved by Quantic Group, Ltd.