Manager-Business Analyst and Project Manager (GxP Applications)

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Job Description

Manager-Business Analyst and Project Manager (GxP Applications)The Business Analyst & Project Manager will lead the end-to-end implementation, harmonization, and continuous improvement of the Unified Quality Platform integrating Document Management System (DMS), Learning Management System (LMS), Quality Management System (QMS), Electronic Forms, and AI-driven Quality solutions. This role involves collaborating with stakeholders to gather and analyze requirements, translating business needs into technical specifications, and ensuring successful delivery and adoption of application solutions.

• Act as a business analyst and project manager for implementation and lifecycle management for various Pharma GxP applications and ensure seamless integration with other site and enterprise applications.
• Strong knowledge and hands on experience Pharma GxP system and its implementation.
• Identify opportunities of process harmonization across organization.
• Collaborate with key stakeholders to understand business requirements and delivering process solutions to business, proficient in analyzing and translating Business/Process requirements to
  
  

technical requirements.

• Facilitate communication and coordination between sites utilizing GxP applications, ensuring
  
  

consistency and standardization in processes and procedures.

• Develop and deliver end user training programs and materials to support the adoption and
  
  

utilization of the Pharma GxP applications and its integration with other systems.

• Coordinate UAT activities with stakeholders, ensuring comprehensive testing coverage and
  
  

validation of system functionalities.

• Escalate complex technical issues to the appropriate IT or support teams for resolution.
• Stay informed about latest system updates, new releases, and industry trends, and make
  
  

recommendations for system improvements and optimizations.

• Establish and maintain effective relationships with business team, project stakeholders, vendors, consultants, and external partners to leverage expertise and resources as needed.
• Monitor and report on quality system performance, usage, and effectiveness, and make
  
  

recommendations for continuous improvement.

• Proactive approach to problem solving and suggest process improvements in Business Processes.
• Ready to travel and work in different time zone as per projects requirement.