Business Analyst (21 CFR Part 11 / SDLC) at SGS Consulting

The IT Business Analyst will be responsible for gathering, documenting, and maintaining requirements in support of business and technical initiatives. The analyst will partner closely with technical teams to define and drive the steps required for successful delivery, ensuring execution through go-live of new systems and managing impacts to legacy and integrated platforms. This role includes ownership of updating and maintaining SDLC documentation to reflect system changes. S/he will work with stakeholders to clearly capture needs and translate them into actionable requirements, define data flows and business processes, and support delivery of key SDLC artifacts such as business and functional requirements and traceability matrices.Key Responsibilities:Support of regulatory applications enhancements, escalated issues and GxP requirements.Work with stakeholders to elicit and validate use cases and requirements, both functional and non-functional for both waterfall and agile projects.Facilitate business requirements gathering process through best practices.Be able to elicit requirements and document them using multiple different requirements writing methodologies.Develop the necessary documentation for IT solution projects - e.g. project objectives & metrics, business requirements, use cases, functional specifications, deployment plans, systems & end-user documentation.Work with the technical teams to ensure that business requirements are understood so that plan, build and run can effectively deliver.Draws from experiences to develop solutions to complex problems that require a high degree of ingenuity, creativity and innovation within the boundaries of industry compliance regulation.Identifies and recommends business process improvements.Ability to articulate complex technical problems and solutions to a wide business audience.Supports training deliverables for stakeholders and technical/functional software support expert during implementations and prototypes/pilots.Ability to work independently, be self-motivated to accomplish tasks, and have great attention to detail.Qualifications:Thorough knowledge of GxP and 21 CFR Part 11 regulations and guidelines.Minimum of 3-5 years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies, in the biotech or pharmaceutical industry.Experience implementing projects within established software development life cycle methodologies.Experience with regulated system projects, including requirements gathering, planning, execution, and deployment.Strong analytical and creative problem-solving skills; Capable of working well under pressure.Excellent communication skills – particularly organizing and presenting project information to management.Capable of multi-tasking across projects; highly organized.

Business Analyst (21 CFR Part 11 / SDLC)

Emma

Requirements and responsibilities

Skills wanted:

Language(s) required:

Admin access needed