Senior Specialist IT MES

NOVARTIS

10 - 15 years

30 - 35 Lacs

hyderabad

Posted:4 days ago| Platform:

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Skills Required

service level networking compliance pharma manufacturing execution system system design continuous improvement information technology operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are seeking a talented and motivated associate to join our Novartis Manufacturing IT team.

About the Role

Key Responsibilities

System Installation and Configuration Perform the installation and configuration of the MES software, working closely with the vendor and IT teams. Ensure proper integration with existing systems and data sources and troubleshoot any technical issues that may arise during the installation process.
Validation Develop and execute validation protocols (e.g. Installation Qualification, Operational and Performance Qualification) to verify the functionality and compliance of our MES with regulatory standards. Your meticulous approach will ensure that our system meets all necessary requirements. In collaboration with business stakeholders, you will ensure that overall validation lifecycle is in place and maintained.
Vendor Collaboration Collaborate with our trusted vendor to gather user requirements and ensure the systems capabilities align with the organizations manufacturing processes. Provide input on system design, assess technical feasibility, and manage the procurement process in coordination with the vendor.
Integration and Digitalization Integrate our solutions into Novartis ecosystem. You will be responsible for end-to-end integration between the system ensuring that relevant data is exchanged and available per business requirements. MES plays an important role on our digital journey hence you will have a chance to impact how we transform our ways of working.
Continuous Improvement Continuously monitor and evaluate the performance of our MES to identify areas for optimization. Work closely with business stakeholders on translation of business requirements into a technical solution. You will be part of the business community where you will have a chance to work with different sites worldwide.
Successful Implementation Ensure the successful implementation of the Manufacturing Execution System within project timelines, budget, and quality standards. This includes completing all necessary tasks, such as requirements gathering, server provisioning, installation, and configuration, while adhering to project goals and delivering the system on time and within budget.
Compliance with Validation Protocols and Regulatory Requirements Validate the functionality and compliance of the MES system by executing validation protocols and ensuring adherence to regulatory standards. The absence of critical or major observations during internal and external inspections indicates a successful compliance record.
Stable Operations and System Uptime Maintain stable operations of the MES system with minimal downtime and interruptions. Measure and track system uptime to ensure optimal availability and performance, meeting the defined Key Performance Indicators (KPIs) as per the Service Level Agreement.
User Satisfaction Gather feedback from end-users to evaluate their satisfaction with the MES system. Conduct regular surveys or interviews to assess the usability, effectiveness, and user experience of the system. A high level of user satisfaction indicates a successful implementation that meets the needs and expectations of the users.

Essential Requirements

Bachelors degree in a computer science, engineering or information technology discipline. An advanced degree and related accreditations a plus.
Experience in GxP environment and understanding of pharmaceutical manufacturing processes and technologies are an advantage but not essential.
Fluent English (written and verbal)
Experience in MES systems.
Digital and Tech savvy

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