Senior Business Analyst

Kindeva Drug Delivery

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows. 

ROLE SUMMARY

Join us as we embrace the future of manufacturing and quality excellence! We're seeking a Senior IT Business Analyst with a passion for innovation and a desire to make a significant mark in the industry. In this pivotal role, you'll work with software applications, tackling unique challenges that will sharpen your technical and analytical acumen. With a spotlight on our core Manufacturing and Quality teams, your work will be highly impactful to our global core business and internal customer groups.

Domestic travel is expected 1-2 timer per quarter and international travel to the UK will be required at least once annually depending upon on business objectives and project scopes. Relocation will be considered for highly qualified candidates.

ROLE RESPONSIBILITIES

• Partner with customers and key stakeholders to understand requirements for systems and ensure systems, and enhancements, meet these needs.
• Participation in all phases of the Systems Development Lifecycle including planning, requirements determination, current state analysis, solution design, estimating, construction, testing, training, implementing, and ongoing support and improvement.
• Support various off the shelf software applications including Trackwise, MasterControl, and Enterprise Asset Management (EAMS).
• Ensure high customer satisfaction for owned IT systems and services.
• Establish ongoing service & support plans and models with related proposed structure, SLA’s and KPI’s for solutions.
• Liaison with others on IT team for technical resources and vendor support teams.
• Coordinate work with vendors and guide contractor and consultant work.
• Lead software testing and participate in software validation.
• Perform fit-gap analysis (tradeoffs) for off-the-shelf software configuration to match business functional requirements
• We believe in investing in our team's professional development. As a senior member, you will have access to continuous learning opportunities, including workshops, conferences, and certifications that keep you at the forefront of the industry.

BASIC QUALIFICATIONS

• Bachelor’s degree in Computer Science (or equivalent education and work experience).
• 5+ year’s experience as IT Business Analyst or Solution Analyst. 
• Strong working knowledge of IT best practices, tools, and system development lifecycle.
• Proficient with general office productivity tools including the MS Office suite.
• Experience and expertise with quality and manufacturing softwares; a plus for specific knowledge of Trackwise or MasterControl.
• Strong working knowledge, and 3+ years of experience, with software validation and FDA 21 CFR regulations.
• Experience working under waterfall project and Agile methodologies.
• Expert use of tools such as Excel, PPT, Visio to build analysis and workflow modeling.
• Demonstrated mastery of requirements writing and risk analysis
• Excellent status report and PPT presentation presenting to business customers and IT management.

California residents should review our Notice for California Employees and Applicants before applying. 
 
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