Business System Analyst

We are seeking aBusiness Systems Analystwith a strong background in regulatedGxP environments,GAMP 5 guidelines, and experience working withSAP or MES ERP systems. The ideal candidate will play a crucial role in analyzing, designing, and optimizing business systems to ensure compliance, efficiency, and operational excellence within a validated environment.

Key Responsibilities:

• System Analysis & Optimization:Assess current business processes and system functionalities to identify areas for improvement and optimization.
• GxP Compliance & Validation:Ensure all business systems adhere to GxP regulatory requirements, with a focus onGAMP 5 best practicesfor system validation.
• ERP System Management:Support and enhance the functionality ofSAP or MES ERP systems, working closely with stakeholders to streamline operations.
• Requirements Gathering:Collaborate with cross-functional teams to gather and document business requirements, translating them into technical specifications.
• Risk & Change Management:Identify risks associated with system changes and implement appropriate mitigation strategies.
• User Training & Support:Develop training materials and provide user support for system enhancements and changes.
• Stakeholder Engagement:Serve as a bridge between technical teams, business users, and compliance experts to ensure alignment on system requirements.

Required Qualifications & Experience:

• Bachelor's degree inComputer Science, Business, Engineering, or related field.
• Proven experience working in aGxP-regulated environmentwithinpharmaceuticals, life sciences, or biotechnology.
• Strong knowledge ofGAMP 5 guidelinesand system validation processes.
• Hands-on experience withSAP or MES ERP systemsfor business operations.
• Excellent problem-solving skills and ability to work in a cross-functional team.
• Strong communication skills to engage stakeholders and drive system improvements