Description
Operations Analyst Pharma/Bio-Tech
Our client is seeking a hands-on Technical Operational Support Analyst with good experience of regulatory processes and technologies particularly with respect to the pharmaceutical sector, good knowledge of Pharma GxP is required.
Essential experience:
*Strong knowledge of SDLC methodologies
*Strong knowledge of GCP and 21 CFR Part 11 Compliance
*Expert in the use of Microsoft Office Suite (Word, Excel, Powerpoint, Project, Visio)
*Experience with ServiceNow and Jira Experience on core ITIL processes
*Minimum 5 years' experience managing complex high-impact IT projects from start to finish and supporting and Administrating Global Development Solutions
*Solid understanding of regulatory processes and technologies particularly with respect to the pharmaceutical sector
*Strong knowledge of business analysis, system design and the production of quality documentation
*Strong problem solving, technical writing and verbal communication skills
Role Summary:
You will be a key member of the Global Development (GD) Solutions organization which is responsible for key activities in managing Build and Run, focusing on GRA (Global Regulatory Affairs). The role requires being the right-hand team member for the GRA System Owner, interacting with business Subject Matter Experts (SMEs) and Corporate IT on the day-to-day basis in support of systems and projects. The role requires excellent business and technical analysis skills and pharma business domain knowledge. This role partners with Global Development Solutions and Business Personnel in understanding business challenges and proposes solutions and provides leadership on support and projects to maintain existing solutions and transitioning new solutions to BAU.
Essential Functions:
*Responsible for ensuring day-to-day operational support to meet business expectations and compliance requirements.
*Vital to the implementation of new systems and upgrades of existing systems. Provides Technical leadership and subject matter expertise on projects to effectively manage business user expectations, timelines, and budget.
*Work with outsourced Managed Service technical support vendor personnel to maintain and transition solutions.
*Works collaboratively with Corporate IT in the management of enterprise systems, the development and adherence to standards and governance, enterprise architecture and common infrastructure
*Understands Global Development "Regulatory" business domain and/or technology very well and can analyse business challenges and present technology solutions.
*Keeping abreast of technology trends and applicability to business needs.
*Functions as point of contact for GDS solutions in support of GDS Team members as well as the functional business units within GD's GRA.
*Works with System Owners, Business Process Owners and end users in understanding business needs and designing creative solutions.
*Contributes on simple projects in roles such as Business Analyst, Project Manager, Solution Architect etc.
oAbility to elicit and gather requirements
oAbility to create simple contextual or system diagrams to illustrate the future state solution
oAbility to create simple project plans to manage and track small projects/enhancement requests
oAbility to create UAT scripts and coordinate testing
*Ensures the standard and compliant support of non-GxP systems in production.
*Establishes best practices in the support of systems, by producing work practices, operating manuals, job aids, etc.
*Must have excellent understanding of related technology and its capabilities.
*Must be able to take on multiple assignments and work independently, with minimal supervision on task implementation.
*Complies with all GRA Regulatory Systems SOPs in the support of GD systems.
The ideal candidate has to be hands on technically and provide support for systems owners for regulatory systems. This could include implementing upgrades for on-premises applications and their deployment, or working with Vendors for their external upgrades & maintenance, end to end support as well as Change Management and Communications; documentation for publishing of submissions, etc.. You will be the go - to person for systems support/Operations.
THIS IS A FULLY HOME-BASED ROLE
£480-£600 per day