GMP Prozess Experte im Bereich der Sterilen Abfüllung (2 Jahre temporär) — Roche

Full description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position With its 1400 employees, the Kaiseraugst (PTM) production centre ensures continuous patient care with high-quality drugs. PTM stands for the highest standards of pharmaceutical production, the largest, most innovative packaging centre of Roche and the supply of more than 120 countries. The possibility The GMP Process Expert in the field of sterile filling (Asset AFL) is responsible for coordinating the activities to comply with GMP requirements in the field of the systems, processes and manufactured products. In addition to adhering to and implementing GMP requirements, as trouble-free and stable production as possible is another priority which is achieved through independent and continuous improvements.This requires good knowledge of the operations and systems as well as very good organizational skills for project processing.

• Production & Process Responsibility: Data-based analysis of performance indicators to increase efficiency, quality assurance and process monitoring in production
• Support for launches, transfers and process issues.
• Documentation & Batch Management : Review by Batch Records, SAP booking control and management of GMP documents.
• Manufacturing Execution System (MES) : Creation, testing and care of recipes, manufacturing regulations and master batch records.
• Quality & Deviation Management: Deviations, Complaints, Changes and CAPAs
• Conducting Root Cause Analysis and Trend Analysis.
• Inspection Management & Quality Risk Management (QRM) Responsibility for risk analyses and their moderation.
• Training & Security: Organisation and implementation of training
• Ensuring safety and environmental protection in the field.
• Projects & KPIs : Support for technical projects in the GMP environment with related documentation; KPI review, standardization and use of LPS tools, process improvement. Who you are
• Completed pharmaceutical, scientific or technical studies or equivalent vocational training
• Multiannual professional experience in pharmaceutical production, development, quality assurance and control or a near industry are of advantage
• Very good communication skills in word and writing in German and English
• High commitment to the job and the employer, openness to new, resilience and flexibility as well as constant performance with changing requirements Behave now and become part of our team to shape the future together! Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitiouss high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an equal opportunity employer.