Koch Business Solutions Looking for IT Infrastructure Qualification Specialist at Bengaluru, Karnataka Full Time

The IT Infrastructure Qualification Specialist will be a part of an international team that designs, develops and delivers new applications for Koch Industries. Koch Industries is a privately held global organization with over 120,000 employees around the world, with subsidiaries involved in manufacturing, trading, and investments. Koch Technology Center (KTC) is being developed in India to extend its IT operations, as well as act as a hub for innovation in the IT function. As KTC rapidly scales up its operations in India, it’s employees will get opportunities to carve out a career path for themselves within the organization. This role will have the opportunity to join on the ground floor and will play a critical part in helping build out the Koch Technology Center (KTC) over the next several years. Working closely with global colleagues would provide significant international exposure to the employees.

Supports the overall management of IT infrastructure related qualifications. Supports all phases of IT qualifications including creation, execution and documentation of qualification plans. Works to ensure new or changed infrastructure component are qualified in accordance with regulatory standards.

A Day In The Life Could Include:
(job responsibilities)

Design and develop qualification plans that comprise deliverables, user requirements, and functional specifications for GxP relevant infrastructure components.

Support the Change Advisory Board (CAB) structure, including weekly meetings, emergency CAB meetings, in house development teams and change owners. Assist in determining if changes are GxP relevant.

Review and write Infrastructure Life Cycle and qualification documentation in compliance with regulations and Business Process Procedures

Prepare test cases and scripts for audit trail to verify qualification after changes to infrastructure components.

Prepare walkthrough narratives and process flow diagrams to identify key GMP controls. Identify processing risks, mitigating controls procedures, control gaps and ineffective internal control procedures.

Execute qualification protocols, prepares deviation reports on system errors, and recommends resolutions. Interacts with the IT business unit management and staff members when deemed necessary.

Proactively highlight opportunities to improve performance in all areas of qualification.

Report on the status of the service provided, including plans for tackling performance or other issues.

Develop and operate effective working relationships with third party suppliers, when there is inter-dependency of more than one for the delivery of a service.

Review documentation for accuracy and compliance to GxP.

Develop and maintain relationships with System Owners, Technical Representatives and Business owners.

Performs Quality Control reviews of qualification activities and deliverables.

Provide objective evidence of qualification. Notify stakeholders if issues arise during qualification.

Assist with software validation activities.

Assess and Qualify Cloud Infrastructure services supporting GxP Applications

Coordinate and execute the infrastructure component/platform test execution efforts

Perform other related duties as assigned by management.

• Knowledge in Microfocus Application Lifecycle Management (ALM) and Vera software to setup and execute test plans and obtain compliant electronic records.
• Knowledge of Service Now
• Proven project management skills that demonstrate the ability to complete assignments in a systematic and timely basis

What You Will Need To Bring With You:
(experience & education required)

• Comprehensive knowledge of the processes around the management of requirements, qualifications and/or validations to support best practices IT controls environment.

Working knowledge in SaaS and/or IaaS and the processes to qualify and/or validate to support IT Compliance.

• Ability to grasp business problems, goals, objectives, and provide alternative solutions
• Solid understanding of requirement specifications, design, development and testing
• Good organizational and project planning skills
• Good interpersonal skills to work effectively with different teams within the organization to achieve common goals and respond positively to situations
• Effective communication skills (verbal and written) for clear and concise communications
• Previous experience working on teams or leading project teams consisting of business and IT resources.
• Proficient in qualification and validation processes in a GxP environment.
• Flexible travel

Experience

• 5+ years qualification writing and executing experience.
• 3+ years Experience in IT Compliance to support medical regulations
• 3+ years Experience in Change Management processes related to IT infrastructure

Education

Associate degree and/or relevant experience, which combine for 5+ years of experience.

Work Hour

Expected to work timing is 12:00 to 9:00 pm IST, flexible to work according to Project needs.

What Will Put You Ahead:
(experience & education preferred)

Experience

• 5+ years experience in a regulated Medical environment
• 2+ years’ experience in Microfocus Application Lifecycle Management(ALM)
• 2+ years’ experience in Service Now Change management process

Education

• Bachelor’s degree in Management Information Systems, Computer Science, or other Engineering disciplines.