AI Ops Plant IT Cluster Lead

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. 

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable.  Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Key Responsibilities:

By default, the Unit Lead JD includes the responsibilities of a Cluster Lead. Additionally, the following skill set is required

1. Ensuring Smooth GxP IT Operations:

• Ensure IT Operations across multiple sites run smoothly.
• Manage system administration and operations in line with procedures and policies.
• Support business continuity to achieve 100% uptime of GxP IT functions.

2. Compliance Management:

• Ensure sites are in compliance with GxP IT Operations at all times.
• Review and ensure adherence to procedures during routine operations.
• Manage QMS notifications and close them effectively to maintain compliance.

3. Project Execution & Delivery:

• Support the implementation of IT solutions by interacting with vendors and ensuring effective solution implementation.
• Evaluate new GxP IT solutions for implementation across sites.
• Provide support during POCs and solution development for timely completion of activities.

4. Business Support Initiatives:

• Implement new business initiatives like MS Teams, MS SharePoint, Yammer, and other applications to support global business initiatives.

5. Internal Customer Relationship Management:

• Build strong working relationships with business users, senior management, and other functions to improve understanding and adoption of IT systems.

6. Liaison and Coordination:

• Act as a liaison between Quality, Engineering, Projects, and other cross-functional teams, providing IT expertise.
• Facilitate continuous improvement initiatives and support digital transformation in Quality and Manufacturing areas.

7. Training and Development:

• Conduct training for users on new and existing software solutions and IT SOPs.
• Train the IT team on new application development technologies and IT SOPs.

8. IT Infrastructure and Security Management:

• Standardize, qualify, and manage IT infrastructure, including retirement, AMC, and reusability programs across sites.
• Oversee IT security management with required coordination.
• Ensure timely security patch updates for Non-GxP and GxP assets.
• Review manual and automated activities to ensure compliance with SOPs and practices.

9. Audit Readiness and Compliance:

• Prepare and maintain documentation for audits and regulatory inspections.
• Ensure all activities and documentation are aligned with GxP Operations and SOPs.
• Conduct pre-audit checks and implement post-audit measures to address recommendations.
• Review SOPs versus practices in terms of all-time audit readiness.

10. Stakeholder Management:

• Engage daily with site leadership and coordinate stakeholder expectations.
• Act as a liaison between departments and senior leadership to foster communication and collaboration.
• Facilitate continuous improvement initiatives to enhance audit readiness and compliance.
• Conduct weekly connects with each leadership team to communicate progress, challenges, and support requirements clearly.

11. End-User Activity and Support:

• Ensure smooth end-user activity across sites.
• Provide training and guidance to the team on GxP requirements and best practices.
• Address and resolve any end-user issues in a timely manner.

12. GxP IT Compliance:

• Ensure plant sites are compliant with GxP IT Operations at all times.
• Regularly review and update procedures to maintain compliance.
• Manage and close QMS notifications promptly to ensure transparency and compliance.

13. IT Solution Implementation:

• Provide necessary support during solution implementation.
• Interact with vendors to ensure effective and timely solution delivery.
• Evaluate and support POC and solution development activities.

14. Liaison with Quality and Engineering:

• Coordinate between Quality, Manufacturing, Engineering, and Projects to bring IT expertise.
• Support new instrument/equipment installations and qualifications related to IT.

15. Training and IT SOP Management:

• Ensure training of users on new and existing software solutions and IT SOPs.
• Conduct IT team training on new application development technologies and IT SOPs.

16. IT Infrastructure Management:

• Ensure IT infrastructure standardization, qualification, retirement, AMC, and reusability program management.
• Proactively address IT and CSV bottlenecks to ensure smooth functioning of Quality and Manufacturing systems.

17. Data Management:

• Oversee data backup, data restoration, periodic reviews, and incident management.
• Review data and controls to ensure compliance with GxP practices.

18. Audit Readiness and CAPA Management:

• Act as the face for audit readiness and provide explanations for inspectors and auditors.
• Review and monitor CAPAs of audit observations and ensure timely completion.
• Conduct periodic reviews to ensure adherence to GxP practices.

19. User Management and Access Control:

• Manage user access and permissions in compliance with regulatory standards.
• Provide guidance on GxP requirements and best practices.

20. IT Security and Patch Management:

• Manage IT security and ensure timely updates of security patches for Non-GxP and GxP assets.
• Review manual and automated activities for audit readiness and compliance.

21. AIOps Thinking:

• Utilize Artificial Intelligence for IT Operations (AIOps) to enhance system monitoring, automation, and proactive issue resolution.
• Implement AIOps tools and strategies to streamline IT operations and improve efficiency.

All time GxP IT Compliance at Plant : Ensuring plant is in compliance state all the time with respect to GxP IT Operations. Effectively checking and reviewing procedures are being followed and complied during routine operations. QMS notifications are being taken and closed wherever required for ensuring the site is in compliant state in order to achieve transparency and compliance in the plant
    
Implement Solutions with Project Execution & Delivery focus :Necessary support being provided during implementation of solution, interacting with the vendor in order to effective solution implementation.

Ensuring Smooth GxP IT Operations at all site in Cluster : Ensuring that IT Operations in the plant are running smoothly. Effective management of system administration and operations. IT Activities are managed in the plant with respect to procedures and policies. Providing necessary support to the Plant for business continuity and maintaining the procedures in plant in order to achieve 100% up time of GxP IT function. 
    
All time GxP IT Compliance at all sites : Ensuring plant is in compliance state all the time with respect to GxP IT Operations. Effectively checking and reviewing procedures are being followed and complied during routine operations. QMS notifications are being taken and closed wherever required for ensuring the site is in compliant state in order to achieve transparency and compliance in the plant

Liaison between Quality, MFG , Engineering, Projects and other Cross functional teams by bringing in the right levels of IT expertise including URS finalization  as per DRL Infosec standard , coordinating  with Vendor / OEM for required implementation.

Ensuring & conducting the training of the users on the new and existing software solutions, IT SOPs. To arrange / conduct the IT team training on new application development technologies and IT SOPs.

Ensuring IT Infra standardization, qualification, retirement, AMC and reusability program management in place for plants.

Proactively clearing any IT & CSV bottlenecks leading to smooth functioning of the Quality and Manufacturing systems.

Responsible for reviewing the data backup, data restoration, periodic reviews and Incident related to IT at plants.

Responsible for audit facing for IT aspects of Manufacturing Equipment and Reviewing, Certifying, and monitoring of agreed CAPAs of audit observations for plants.

Ensuring Compliance to regulations on electronic data, operational procedures, and periodic reviews of data and controls that helps in adherence to GxP Practices.

Key Performance Indicators:

• Achieve all tasks as per Service Level Agreements (SLAs).

Mandatory Skills:

• Extensive knowledge of Pharma IT Operations & Compliance, Plant IT Operations, IT Infrastructure, Networking, IT Security, IOT , AIOPs  , MFG Systems / Controls and Computer System Validation.
•  
• Expected Skills:
• Leadership, time management, stakeholder management, and review processes.
• Ability to manage IT operations for multiple sites effectively.

Experience:

• Minimum 10-12+ years of experience in relevant fields.

B.Tech or above or with relevant skill set

Certifications in IT -  Empower, MES, DCS, Data Historian, L2 integration, and Cloud Computing.

AI Ops Plant IT Cluster Lead - IT Operations and Compliance is responsible for ensuring the smooth functioning of GxP IT Operations across multiple sites. The role involves effective management of system administration, IT activities, and compliance with GxP guidelines. The Cluster Lead will play a crucial role in supporting business continuity, implementing IT solutions, managing IT security, and fostering strong relationships with internal and external stakeholders.

About the Department
Digital Process and Excellence (DPEx)
Our digital transformation journey is led by the DPEx team and is structured along the lines of Digitalize the Core and Transform with Digital.
With a mandate to ensure continuous process improvement and drive patient centric innovation, it spans all functions and operations. In other words, you could be working on projects to expedite research outcomes one day, designing customer engagement platforms the next and simplifying warehouse processes the third.
Some its priorities are:
• Reimagine Dr. Reddy’s as a ‘platform-based’ organization.
• Create Data as an asset that brings competitive advantage and business impact.
• Create Digital solutions that make the lives of our patients and customers easier and better.

Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/