Title:  Senior Manager - 2

Position: Senior Manager – Corporate Quality Projects

Grade: G9B

Job Location: Mohali, Punjab

Job Profile:

· Understanding of platform/system qualification and its cross site implementation to assure the GxP computerized systems are compliant with applicable regulatory requirements.

· To support the validation of GxP Application Systems including Enterprise Systems, Backup systems, electronic inventory and user access management system and other computerized systems to comply with regulatory guidelines.

· To define Validation Strategy & plan, review and system readiness CSQMS documentation.

· To support the various phases of Computer System including Planning, Qualification, Implementation, Maintenance and retirement activities by ensuring compliance with internal / external regulatory requirements.

· Collaborate with Business team to prepare Business case studies.

· Gather Project business and technical requirements in order to develop project estimates.

· Work with Digital platform and application team for future developments and releases.

· Create and execute project plans with IT leads, and revise as appropriate to meets changing needs and requirements.

· Identify vendors and perform vendor application evaluation along with IT and Business users.

· Collaborate with IT Project Managers to execute projects, ensuring that teams have appropriate product and technical specification, direction, and resources to deliver products effectively by establishing realistic estimates for timelines and ensure project meets deadline.

· Work with IT project manager to ensure effective and efficient communication and execution of program and Train business users.

· Provide support to sites on handling/troubleshooting technical/understanding issues related to Global applications. Handing of Incidents related to functionality of Global application; participate in investigation process to find the root cause and implementation of CAPA.

· Ensure each issue is tracked and resolved in timely manner as a part of procedure elaboration, enhancement.

· Responsible for management of Global Standard Operating Procedure and Global System User Manual for electronic systems.