Job Description
We are seeking a Business Systems Analyst with a strong background in regulated GxP environments, GAMP 5 guidelines, and experience working with SAP 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 on GAMP 5 best practices for system validation.
* ERP System Management: Support and enhance the functionality of SAP 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 in Computer Science, Business, Engineering, or related field.
* Proven experience working in a GxP-regulated environment within pharmaceuticals, life sciences, or biotechnology.
* Strong knowledge of GAMP 5 guidelines and system validation processes.
* Hands-on experience with SAP or MES ERP systems for 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