Lab Business Analyst
il y a 2 semaines
Overview:
The Mithra CDMO is currently looking for a **Lab Business Analyst** to expand the QC Team for its integrated R&D and manufacturing platform based in Flémalle, Belgium. The Lab Business Analyst is a critical role on the Laboratory Information Management System (LIMS) project team.
**Responsibilities**:
He/She will:
- Review, analyze and capture business requirements and user needs.
- Identify and recommends business process improvement opportunities to enhance end-user experience.
- Document requirements, define objectives and formulate solutions to harmonize business processes.
Work directly with end users and system owners as well as vendors to document, analyzes and provides technical solutions to achieve business goals.
- Maintain software performance tuning, analyze workload and computer usage, maintain interfaces with outside systems, analyze downtimes, analyze proposed system modifications.
- Provide technical expertise for troubleshooting and incident resolution to user community, as well as, liaising with IT experts for problem.
Lead validation activities for LIMS/ELN and Empower CDS in accordance with GMPs, 21CFR Part11 and MHRA and ensure compliance over lifecycle of system.
- Ensures documentation is completed in support of activities, quality incidents and regulatory requirements (e.g., system SOPs, change controls, validation documentation).
- Perform LIMS/ELN and Empower CDS system periodic reviews, user account review and other computer compliance processes, as assigned.
- Maintain an overall knowledge of processes to ensure effective change management for LIMS/ELN, Empower CDS and other responsible IT systems.
- Demonstrate technical expertise with LIMS and provides expert analysis advice and recommendations.
- Responsible for fronting regulatory inspections or audit (internal and external) as well as fields questions during regulatory inspections or audits.
Qualifications:
- Masters or Bachelor’s degree in scientific discipline or computer sciences or significant equivalent work experience in an equivalent role.
- Minimum of 3 years’ experience with business process design and improvement, in the scope of large systems implementation, preferably in a laboratory environment.
- Experience with Empower CDS and LIMS/ELN solutions, in understanding and complying with relevant regulations (e.g.: GMP, 21 CFR Part 11, MHRA).
- Knowledge of critical systems supporting the laboratory environment (e.g. LIMS, electronic notebooks, Chromatography systems ).
- Familiar with software development process.
- Capable of planning, organizing, and prioritizing a range of technical and change-management activities.
- Team work: actively involved in team activities.
- Works and co-operates with others, shares the relevant information.
- Has an open, positive, non-competitive stance towards others in the team. Knows and understands team goals.
- Customer Focus: identifies, implements, and continuously improves work processes.
- Fluent in French and minimum B1 in English.
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