GLP System Owner & Analyst

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

This role is for a GLP System Owner and Analyst within the pRED Computer System GxP Organization in Basel. The primary responsibilities include the implementation operation maintenance and support of GLP systems for the pRED Pharmaceutical Sciences GLP Test Facility.

The System Owner will ensure that the systems adhere to Swiss-based Good Laboratory Practices (GLP) and meet regulatory requirements. Additionally as a System Analyst the role involves managing and supporting computer system validation projects to meet the business data processing needs while maintaining regulatory compliance.

The Opportunity

The responsibilities include :

System Lifecycle Management : You will be responsible for the full lifecycle of GLP systems including implementation operation maintenance and support in compliance with regulatory and internal policies.

Project & Validation Management : You will lead and support GLP computerised system validation projects from defining user requirements and data workflows to coordinating development and testing activities.

Strategic Planning : This role includes both short and long-range planning for GLP digital services and contributing to key system maintenance concepts like backup security and disaster recovery.

Resource Coordination : You will manage and coordinate both internal teams and external vendors to ensure successful project implementation and ongoing system operations.

Compliance & Audits : You will maintain a deep understanding of GLP regulations and support internal and external audits.

Who You Are

5 years of experience leading and managing GxP systems throughout their entire lifecycle.

Proven expertise in Computer System Validation (CSV) and device qualification specifically with FDA 21 CFR Part 11 and GLP (i.e. OECD Principles of Good Laboratory Practice).

Proficient in Agile Scrum and other methodologies with strong skills in tools like JIRA and ServiceNow.

A flexible pragmatic and solution-oriented mindset able to manage multiple parallel tasks and work collaboratively with diverse teams.

Excellent communication skills in English adept at leading effective meetings and workshops.

Awareness understanding and possible experience with emerging technologies such as DevOps and AI.

#ComputationCoE

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Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.

Required Experience :

IC

Key Skills

SQL,System Design,.NET,Crystal Reports,EDI,Windows,Microsoft SQL Server,Visio,Visual Basic,SDLC,Systems Analysis,Oracle

Employment Type : Full-Time

Experience : years

Vacancy : 1