Senior Specialist, Lab Execution System, Business Analyst

About the role

Based in Hyderabad, join a global healthcare biopharma company and be part of a 130-year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Join a team that is passionate about using data, analytics, and insights to drive decision-making and create custom software, allowing us to tackle some of the world's greatest health threats. Our Technology Centres focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our company's IT operating model, Tech Centres are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each Tech Centre helps ensure we can manage and improve each location, from investing in the growth, success, and well-being of our people to making sure colleagues from each IT division feel a sense of belonging, to managing critical emergencies. Together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centres. Role Overview As part of our global Lab Transformation effort, we are seeking a Lead IT Business Analyst to support SDLC development and GMP validation of the Biovia OneLab platform for Quality Control labs. This role will partner with laboratory, quality, IT, and vendor stakeholders to define requirements, support solution delivery, and ensure the platform meets business, compliance, and validation needs in a regulated environment. The Lead IT Business Analyst will help ensure compliance with FDA 21 CFR Part 11 and data integrity standards, while collaborating with QA, IT, business, and laboratory teams to support system changes and updates. This role also reviews and mentors contributors, drives documentation standards, and ensures consistency and accuracy across the Biovia OneLab platform. What will you do in this role: Elicit business requirements for QC Lab operations. 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. Contribute to the development of detailed project plans. Develop and maintain comprehensive project documentation, including requirement specifications, use cases, and user testing. 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. Develop SDLC documents (Process Maps, Workflows, QAP, RS, UAT, QASR, SOPs, etc.) What Should you have: 7 - 11 years 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 the Laboratory Information Systems (LIMS) or Laboratory Execution System (LES). 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. Experience supporting large-scale, global, complex projects, associated with digital transformation/optimization initiatives. Experience with Computer System Assurance (CSA).

Requirements

• Bachelor's degree in a relevant field (e.g., Life Sciences, Information Technology).
• Experience with Agile methodologies and project management tools.
• Experience with system-system integrations and instrument integrations

Benefits

Additional Information

Job Description Senior Specialist, Lab Execution System, Business Analyst

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