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Business Analyst - Life Sciences (GxP Environment) Jobs (On-site work)

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Associate Software Engineer
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India , Hyderabad
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Not provided
amgen.com Logo
Amgen
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Until further notice
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Associate Software Engineer
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Location
India , Hyderabad
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Not provided
amgen.com Logo
Amgen
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Until further notice
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Discover rewarding Business Analyst - Life Sciences (GxP Environment) jobs, a critical nexus between scientific innovation, business processes, and regulatory compliance. Professionals in this specialized field are essential to the success of pharmaceutical, biotechnology, and medical device companies. They act as interpreters and facilitators, bridging the communication gap between business stakeholders—such as lab scientists, quality assurance teams, and commercial departments—and IT developers or system implementers. The core of their mission is to ensure that technology solutions not only meet business needs but are also fully compliant with the stringent Good Practice (GxP) regulations mandated by global health authorities like the FDA and EMA. A typical day involves a wide array of responsibilities centered on requirements management and process improvement. Business Analysts are responsible for eliciting, analyzing, documenting, and validating detailed business and user requirements. They create essential project artifacts, including Business Requirements Documents (BRDs), Functional Specifications, User Stories, and process flow diagrams. A significant portion of their role is dedicated to facilitating User Acceptance Testing (UAT), writing test scripts, and guiding users through the validation process to ensure systems function as intended and are fully audit-ready. They also play a key part in change management, helping to train end-users and ensuring smooth adoption of new systems and processes. The skill set required for these jobs is a unique blend of analytical prowess, technical understanding, and regulatory knowledge. Successful candidates typically possess a strong analytical and problem-solving mindset, with exceptional communication and stakeholder management skills to navigate complex organizational structures. A fundamental understanding of software development lifecycles (SDLC), including Agile and Waterfall methodologies, is crucial. Most importantly, they must have a solid grasp of GxP principles, with knowledge of key regulations like 21 CFR Part 11 for electronic records and signatures, and a familiarity with Computer System Validation (CSV) processes. A bachelor's degree in life sciences, computer science, business, or a related field is commonly required, with many professionals also holding certifications like CBAP (Certified Business Analysis Professional) or specific GxP training. For those with a passion for both science and technology, Business Analyst - Life Sciences (GxP Environment) jobs offer a dynamic and impactful career path. These professionals are the unsung heroes who ensure that life-saving therapies are developed and manufactured using reliable, efficient, and fully compliant systems, directly contributing to patient safety and public health. Explore opportunities in this vital field today.

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