The Plant Engineer F&U has a multitasking/cross functional role whereby shall be responsible for supporting as technical expert shall support the delivery of projects of varying co…
Supports creation of the aseptic process validation concept for a new Isolator Filling Line and Lyophilisation process Supports creation of aseptic process validation reports, pro…
Lead and drive formulation development and manufacturing activities for assigned projects, ensuring scientific and technological excellence focus on parenteral drug products Colla…
Classic assistance tasks e.g. calendar management, booking flights and expenses Process orders/bills/supplier communication in SAP Scheduling global appointments Meetin…
Deliver robust market and revenue model projections through extensive data analysis and collaboration on a global level Translate data into trends with strategic importance and bu…
Monitoring, analysis and handling of issues occurring during release testing Preparation and execution of deviation notifications, variances, changes, out of specifications and CA…
Take responsibility of one defined area along the user journey. (Ex. Diagnosis workflows, simulation etc.) Apply various UX methodologies to help the teams define the user prob…
Provide Quality oversight of external GDP operations, e.g. lead QMS activities, including Complaints, Deviations, Change Control, Audits, Self-Inspections, and Training Ensure GxP…
Ownership for the processing of the assigned patient starting material in the clean room environment. Ability to gown aseptically and work in a clean room environment (ISO 8, 7 an…
Support life-cycle management to ensure timely regulatory submission within ICO Region (Latin-America, Middle east, Africa, CIS, Russia, Turkey and eastern Europe (non-EU) Coll…
Responsible for the design, plan, perform, interpret and report results of formulation and process development for liquid and lyophilized parenteral drug products of small molecule…
Manage and perform biological material supply, receipt, registration, shipment, returns, verification activities, retrievals, inventory searches, and identify and resolve discrepan…
Create MSAT process documents and GMP risk assessments supporting technology transfer to a new facility Evaluate change impact to process and product quality Process troubleshoot…
Oversight of FATs (Factory Acceptance Tests) and SATs (Site Acceptance Tests) Execution of IV (Installation Verification), SU (Single Use) and OFT (Operational Feasibility Testing…
Determine the multi-language booklet labels MLBLs specifications (size, type) Ordering of booklets Request and review quotes/purchase orders for booklet orders Track the timelin…
Hold all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems Support the development, reviews and releases qualifica…
Executes Weigh and Dispense manufacturing operations and/or material management activities (including preparation of materials managed in Kanban, Kitting activities, and Glucose re…
Performing all warehouse and distribution activities in compliance with requirements and the corresponding procedures. Performs cleaning of workplace Performs GMP compliant docum…
Managing change execution and change Coordination in the area of Global Operations Consumables with internal stakeholders (e.g. Quality Management) and external contract manufactur…