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About the role
Role Overview: You will be part of the global Lab Transformation effort as an IT Business Analyst, focusing on supporting SDLC development and GMP validation of the Biovia OneLab platform for Quality Control labs. Your responsibilities will include creating, editing, and maintaining documentation such as SOPs, work instructions, and validation records. Working under the guidance of the Lead IT Business Analyst, you will ensure that documents align with GxP and data integrity requirements, assisting with formatting, version control, and document management processes. Collaboration with technical teams to gather information, incorporate feedback, and build foundational knowledge of Biovia CIS Pro and regulated documentation practices will be a key aspect of your role. Key Responsibilities: - Elicit and document business requirements for lab materials management. - Conduct stakeholder interviews and working sessions to gather insights and clarify needs. - Analyze and translate business requirements into functional and technical specifications for the selected technology. - Collaborate with project teams to ensure alignment in the design and implementation of systems and processes. - Develop and maintain comprehensive project documentation, including requirement specifications, use cases, and design documents. - Facilitate discussions to ensure stakeholder understanding and agreement on requirements and design. - Conduct gap analysis to identify discrepancies between current processes and desired outcomes. - Support the design and implementation of solutions that comply with regulatory standards in the GxP environment. - Assist in user acceptance testing (UAT) to ensure that solutions meet business requirements and operational needs. - Provide training and ongoing support to end-users on new systems and processes. - Perform light coding, database querying, and system configurations as needed to support project goals. - Draft SDLC documents (Process Maps, Workflows, RS, UAT, SOPs, etc.) Qualifications Required: - 3-7 years of proven experience as a Business Analyst / Technical Analyst in the regulated GxP pharma lab environment. - Strong understanding of regulatory requirements and compliance in the pharmaceutical industry. - Experience with Laboratory Information Systems (LIMS) or Laboratory Execution System (LES). - Experience with system-system integrations and instrument integrations. - Experience supporting large-scale, global, complex projects associated with digital transformation/optimization initiatives. - Familiarity with testing tools and methods e.g. JIRA, Microsoft Teams, etc. - Technical skills in light coding, database querying (e.g., SQL), and system configurations. - Excellent analytical and problem-solving skills. - Strong communication and interpersonal skills to effectively engage with stakeholders. - Ability to work independently and as part of a cross-functional team and manage multiple priorities in a dynamic environment. Role Overview: You will be part of the global Lab Transformation effort as an IT Business Analyst, focusing on supporting SDLC development and GMP validation of the Biovia OneLab platform for Quality Control labs. Your responsibilities will include creating, editing, and maintaining documentation such as SOPs, work instructions, and validation records. Working under the guidance of the Lead IT Business Analyst, you will ensure that documents align with GxP and data integrity requirements, assisting with formatting, version control, and document management processes. Collaboration with technical teams to gather information, incorporate feedback, and build foundational knowledge of Biovia CIS Pro and regulated documentation practices will be a key aspect of your role. Key Responsibilities: - Elicit and document business requirements for lab materials management. - Conduct stakeholder interviews and working sessions to gather insights and clarify needs. - Analyze and translate business requirements into functional and technical specifications for the selected technology. - Collaborate with project teams to ensure alignment in the design and implementation of systems and processes. - Develop and maintain comprehensive project documentation, including requirement specifications, use cases, and design documents. - Facilitate discussions to ensure stakeholder understanding and agreement on requirements and design. - Conduct gap analysis to identify discrepancies between current processes and desired outcomes. - Support the design and implementation of solutions that comply with regulatory standards in the GxP environment. - Assist in user acceptance testing (UAT) to ensure that solutions meet business requirements and operational needs. - Provide training and ongoing support to end-users on new systems and processes. - Perform light coding, database querying, and system configurations as needed to support project goals. - Draft SDLC documents (Process Maps, Workflows, RS, UAT
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