Asset Excellence Manager (befristet, 2 Jahre) — Roche

Full description

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The Position The Asset Excellence Manager in the field of Sterile Filling Asset GEF is responsible for coordinating the compliance activities around the plants, processes and manufactured products in his area. As trouble-free and stable as possible production is a further focus in addition to GMP compliance, which is achieved through independent and continuous improvements.

It is the responsibility of the AE Manage that the production facilities are GMP-compliant in accordance with the current national and international GMP regulations and Roche-internal requirements. This requires a good knowledge of operational processes and facilities as well as very good organisational skills for project management.

The job holders are contacts internally and externally with regard to the initiation, coordination and implementation of all necessary measures to achieve and maintain GMP compliance. It shares responsibility for compliance with GMP rules in the area. For this purpose, the vacant has professional authority in GMP matters towards the entire staff of the area or support functions. The focus of responsibility and the associated responsibility are determined in agreement with the supervisor.

The possibility

• Process activities & production processes: optimization, testing, validation & qualification of plants and products, contact person for processes & systems, cooperation in launches, transfer projects & process validations, definition of production & process processes, process monitoring & support for compliance issues.
• Batch Record Review & Booking Control: Check for completeness & correctness of batch records, transfer of documentation to QA & batch closure, comparison of balance-sheet quantities with SAP data, correction bookings & inventory bookings.
• MES Activities & Documentation Management (PQS): Creation & Testing of Recipes & Manufacturing Regulations, Coordination & Approval of Master Batch Records, Creation & Maintenance of GMP Documents, Assurance of Current PQS Processes.
• Deviation & Change Management (Deviations, Complaints, CAPAs, Changes): Processing of Events, Deviations & Complaints as Owner or SME, Performing Root Cause Analysis (RCA) & Trend Analysis, Processing of Changes as Change Owner.
• Hygiene & Zone Concepts: Implementation & compliance with the hygiene, cleaning & Zone Concept in the responsible building/area.
• Inspection management: Representation of the area as SME in inspections & audits, preparation, coordination & support of inspections / audits (internal & external), coordination of action tracking & timely processing.
• Quality Risk Management (QRM): Responsibility for the QRM process in the scope, planning, creation & moderation of risk analyses, support as SME.
• Training & training: Creation of training & training concepts, organization & implementation of training, management of training profiles, assumption of tasks as a “training partner”.
• KPI, LPS & standardization: Regular review of key figures & derivation of improvements, application of LPS tools, support of problem solvers, alignment & harmonization between teams, participation in relevant planning & control meetings.
• Project management: management, coordination, support & cooperation in local and global projects, as well as safety & environmental protection: ensuring compliance with safety & environmental regulations, promoting operational safety & implementing accident prevention measures.
• Readiness for Picetting Work When Needed

Who you are

• Completed pharmaceutical, scientific or technical studies or vocational training combined with many years of professional experience (minimum 5 years);
• professional experience in pharmaceutical production, development, quality assurance and control or close industry is beneficial;
• very good communication skills in word and writing in German and English.
• High commitment to the job and the employer, openness to new things, resilience and flexibility as well as constant performance with changing requirements

Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!

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 ambitions 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.