seekers for Sr. Analyst - Technical

Job Description

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.The Senior System analyst will ensure achieving service excellence according to our commitment to the IT user community in supporting our highly secure Software Systems used by R&D Healthcare users. This position will ensure support continuity for healthcare business spread across the globe.You are curious, strive to deliver with highest quality and enjoy the team spirit of a highly motivated international team. You understand that communication is a key success factor for your development.As we work for patients maturity, availability and continuous improvement of our IT systems is critical. You will therefore work closely with business users to understand, analyze, and document the business requirements and follow the defined Computer system validation (CSV) process and SOPs and prepare the required documentation . You will also work with development team to explain/clarify the business requirements and support the team to complete the deliverables on time with highest quality. Responsibilities:
• Experience in supporting applications in a Global Pharmacovigilance department. Candidate should have experience dealing directly with end users.
• Experience in supporting Signal detection & Pharmacovigilance Safety Systems (e.g. Oracle Empirica/Aris Global ARISg).
• Experienced in database topics including Oracle, PL/SQL, SQL & Performance Tuning
• Working knowledge on webservers like Jboss and ETL like Informatica.
• Working knowledge on Gateway systems like AxWay is a plus.
• Working knowledge of Linux, Tomcat & Unix Shell scripting is a plus.
• Experience in Customization and Automation.
• Plan, install and maintain highly complex systems.
• Evaluate new applications and identifies systems requirements.
• Evaluate new IT developments and evolving business requirements and recommend appropriate system alternatives and/or enhancements to current systems.
• Prepare communication and make presentations on system enhancements and/or alternatives. Evaluate, optimize, harmonize and standardize existing systems.
• Create and update system documentation. Monitor quality standards and ensure failure-free operation. Consider compatibility of different systems.
• Solve a range of straightforward problems through knowledge and technical experience in own discipline with a moderate level of guidance.
• Analyze information and possible solutions and make independent judgments, decisions and recommendations.
• Support the on-going regulatory compliance of the IT components for defined services.
• Review and approve regulatory system changes and documentation.
• Support periodic reviews of the entire system and compile related reports during operation phase.
• Support the on-going regulatory compliance of the IT components for defined services
• Understand how the team integrates with other teams in order to achieve overall objectives of the area and builds knowledge of the organization, processes, customers and key business drivers.
• Experience in working on CSV Process.
• Experience in understanding, analyzing and documenting business requirements.
• Help development team in drafting FRS and provide the support throughout the development lifecycle for any clarification on business requirements.
• Write business test cases for the finalized User requirement specifications.
• Document and track business change requests.
Minimum Qualifications:
• Minimum of 4-9 years of experience
• Minimum of bachelor s degree or applicable experience within Information/Computer systems with focus on Qualification of R&D applications
• Previous experience in the biotechnology/pharmaceutical or related industry with implementing and validating computer systems that manage regulated information.
• Working knowledge of IT infrastructure qualification processes and IT operating procedures
• Knowledgeable in 21 CFR Part 11, GAMP, GxP regulations.
• Thoroughly familiar with Quality & GxP IT compliance requirements.
• Excellent written and verbal communications skills.
• Working knowledge of information security and best practices.
• Good understanding of CSV process.
• Experience in running meetings / workshops to gather requirements.
• Experience in writing detailed test cases to validate the deliverables against the business requirements.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!Curious Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html ,

Keyskills :
computer system validation21 cfrunix shell scriptingsystem analysis