Business Analyst - Mumbai, India - PharmaLex

    PharmaLex
    PharmaLex Mumbai, India

    1 week ago

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    Understand current pharma/biotech industry techniques/ conventions, Standard Operating Procedures (SOPs), WPs and project requirements according to regulatory, ICH and GCP guidelines for elicitation, analysis, and specification Communicate technical concepts to non-technical audiences, and PV business concepts to technical audiences.

    Develops System functional requirements documentation in the form of user stories, process flows, and user acceptance criteria, Prototypes/produces system documentation data models, data flows, and process flows.

    Supports CSV and UAT teams.
    Explain customer's requirements correctly to the internal implementation team. Prepare and explain demo environment of system as necessary for implementation workshops.

    Be a "go to" Subject Matter Expert (SME) for SQRC(Safety, Quality, Regulatory Compliance) Systems areaDefines project/system requirements for end to end SQRC Systems area by identifying key deliverables, phases and acceptance criteria, to guide stakeholders and developers/engineers to help drive the development of new applications and featuresFormulates and defines business scope and objectives of the relevant process area through research and fact-finding combined with an understanding of business system and the industry requirements.

    Performs detailed Functional/data requirements gathering and analysis to provide high quality and detailed requirements, ensuring the closest involvement and agreement from the user community.

    Responsible for overall quality of requirements matching to business solution expectations/ needs.
    Consults with multiple stakeholders (e.g. the sponsor / business users/superusers/process owners etc) to construct the system requirementsStakeholder management
    • Works with stakeholders in all business units to formulate scope and objectives for new initiatives.
    Partners with business stakeholders and business engagement managers to prioritize, analyze, define and manage backlog by gathering enhancement requests and helping with project requests as the business needs evolve.

    Provide an oversight on operational activities to the internal team, and have a strong understanding of budget, and scope of work for assigned projects.

    Analyzes the current business environment to detect critical deficiencies and identify improvement opportunities.

    Responds to software development platform questions and troubleshoots efforts by having a thorough understanding of the business processes and flows, thereby enabling the analysis of business requirements and the development of solutions for the business functions.

    Create, update and follow-up support/change control tickets with details, owner and due datesSystem/Solution ownership from audit readiness perspectiveUpdate and maintain a Requirements Traceability Matrix(RTM).Vendor relationship management for Systems in scopeYour Profile+6 Years of experience with at least three years in a similar roleExperience in developing functional requirement & design specifications for system implementations adhering to GxP compliant standardsGxP System Ownership experienceProject scope definition and scheduling/ tracking experienceUnderstanding of project management methodologiesExcellent interpersonal skills, including the ability to represent the group in a business/client facing roleAbility to take responsibility for high quality and on-time project deliveriesSelf-motivated, individual contributor with ability to motivate fellow team membersStrong negotiating skills.

    Strong problem-solving skillsStrong organizational skills with proven ability to handle multiple tasksWe offerA collaborative and diverse work environment that values innovation and inclusivity.

    Opportunity to join a fast paced growing Global MNC and conquer exciting and varied challenges alongside a talented teamAbility to work independently and collaborate effectively in a global, cross-cultural environment.

    Flexible working hours striking a good work life balanceBusiness interaction with nearly all branches of the company across 5 continentsA broad range of initiatives for personal development and professional training