Vikas Monga

The role of the Medical Affairs IT Lead involves overseeing global projects within a challenging setting. Possess expertise in multiple IT technologies, including MS Azure Cloud, database management, DevOps, AI, Agile Project Management for Bespoke applications and computer system validation. Furthermore, they demonstrate a deep understanding of pharmaceutical processes and regulations, such as 21 CFR Part 11 and US FDA regulations. Additionally, they have successfully managed intricate enterprise application upgrades and migrations across diverse environments. Their knowledge extends to various tools like HP ALM for testing, PPM for project portfolio management, Service Now, DevOps and MS Projects. In summary, the Medical Affairs IT Lead assumes a vital role in the organization's IT project/program management perspective.

• Participated in planning process to achieve corporate objectives.
• Applied creative reasoning and logic to resolve complex and specialized managerial issues and develop sound solutions.
• Collaborated with department heads to establish goals and work plans.

Responsible for managing Global Medical Affairs Projects, Program /Project Management for business and regulatory critical global COTS and Be-Spoke applications deployment. Ensuring timely delivery of these business critical Global application in a complex matrix Organization. Responsibility also includes fully owning these applications from the Project life cycle perspective. Ensuring good governance of the projects and using strategic practices to reduce operational cost of the projects. Also ensuring validation state of the applications should be maintained through out during the project life cycle to meet pharma regulatory requirements.

• Administered operating budget, approved expenditures and implemented budgetary adjustments.
• Managed budget implementations, employee reviews, training, schedules, and contract negotiations.
• Introduced new methods, practices, and systems to reduce turnaround time.

Experienced in Clinical, Safety, and Medical domains, I have served as a Subject Matter Expert (SME) in these areas, providing valuable insights and guidance. As a Project Management and Technical Lead, I have successfully led and managed projects for global clients, ensuring their satisfaction and delivering exceptional results. My expertise extends to IT technologies, where I have played a pivotal role in implementing and overseeing various technical initiatives. With a strong track record in project delivery and client management, I am adept at leading cross-functional teams, driving collaboration, and achieving project milestones. My combination of subject matter expertise and technical leadership has consistently contributed to the success of global projects and the overall growth of organizations.

In addition to my expertise as an SME in Clinical, Safety, and Medical domains, my knowledge of computer system validation and consulting experience in the Life Science domain has been instrumental in delivering successful projects for global clients. By leveraging my understanding of regulatory requirements and industry best practices, I have effectively ensured the compliance and validation of computer systems throughout project lifecycles. Through my consulting experience, I have provided valuable guidance to clients, helping them navigate complex challenges and achieve their project objectives. This combination of computer system validation knowledge and consulting experience in the Life Science domain has consistently contributed to the successful delivery of projects for global clients.

During my tenure as a member of the Argus Safety Release Management team, my primary responsibility was deploying the Oracle Argus suite of applications for global Pharma clients, customizing them to align with their unique business processes. Post-deployment, I played a crucial role in ensuring the seamless release of the system, following Agile methodology to maintain efficiency and flexibility. To meet client requirements, I underwent comprehensive training to adhere to their Standard Operating Procedures (SOPs), ensuring compliance and regulatory adherence. Working with two of the top 10 Global pharma clients provided me with valuable exposure to diverse projects and deepened my understanding of the industry's complexities.

• Determined proper methodologies and procedures to use based upon project specifications.
• Liaised between IT infrastructure team and other personnel to assist with resolution of system issues.
• Professionally interacted with clients to assess business requirements and determine software needs.

In a consultant or contractor capacity, I actively collaborated with international clients of the company, operating within the Oracle Life Sciences domain and specifically within the Release Management Team. By employing Agile methodology, our team effectively executed multiple deployments in the Pharmacovigilance (PV) field. Given the stringent regulatory standards across different countries, it was imperative for us to thoroughly understand and adhere to the specific regulatory requirements of each country. This involved gaining a deep understanding of the client's processes and ensuring compliance with the necessary certification prerequisites.

• Performed initial assessments during meetings with assigned clients.
• Evaluated situations and delivered targeted solutions using various tools and resources.

My areas of expertise encompass various regulatory standards and frameworks, including cGMP, cGCP, cGLP, GAMP5, 21 CFR Part 11, SDLC, EU ANNEX 11, and PIC/S, all within a GxP environment. I have actively contributed to global projects for prominent companies in Pune, where I played a pivotal role in validation activities for diverse categories of GAMP applications. Furthermore, I have conducted comprehensive gap analyses and successfully implemented essential QMS processes. Throughout my experience, I have served as an independent quality reviewer for a range of systems, including LIMS Watson, Oracle Clinical Systems, CTMS systems, and PV systems such as Argus and AERS. I possess familiarity with GAMP 4 and GAMP5 category 3, 4, and 5 systems, as well as ITIL and QMS systems. Additionally, I have conducted practical training sessions on computer system validation (CSV), providing a hands-on approach to the subject matter.

As the Head of Technical Service Delivery, my responsibilities involve validating and implementing life sciences products for global clients. These products include Oracle Argus, Oracle Clinical, TMS, Remote Data Capture, Clinical Trial Management System, LIMS Watson, LIMS NuGenesis, Millenium, and Empower. I perform validation of computer systems and maintain compliance with GxP guidelines. Furthermore, I oversee the implementation of Change Control Management in SDLC and ensure the validation of pharma applications by adhering to GxP guidelines, GAP Assessment, GAMP category classification, 21-CFR-Part 11, and EU Annex 11. I conduct periodic reviews of applications to identify areas of simplification and continuous improvement, and engage in discussions with internal crossfunctional teams to mitigate risks and prepare and analyze a risk-based validation life cycle for GxP systems. Additionally, I evaluate risks against regulatory and IT requirements to ensure compliance and prepare documents following GDP guidelines. My role also involves facing and performing vendor or supplier audits, regulatory inspections, and compliance checks, and collaborating with cross-functional teams like end-users, IT, and QMS. I plan, monitor, prepare, review, and approve all CSV artifacts to ensure compliance with SOPs and regulatory requirements in a timely manner. I also conduct training on validation and SOPs and manage Oracle and MSSQL databases.

With over 15 years of experience in IT solutions, support, and project management, I bring a strong background as a technology analyst, consistently achieving successful outcomes. My expertise lies in the development and execution of IT and IS plans, IT budgets, and business and enterprise IT strategies. Additionally, I excel in providing comprehensive enterprise support services, encompassing Oracle databases, enterprise help desk support, and computer system validation to meet the requirements of 21 CFR Part 11.

Proficient in a wide range of technologies, I possess advanced skills in Microsoft SQL Server, Citrix, Documentum Content Management & eROOM, web top, Documentum administrator, Oracle database, Track IT, HP OVO, VPN, VMWare, SAN, NAS, Legato Enterprise backups automation, HA cluster, and more. This diverse skill set allows me to effectively navigate and manage various IT systems and infrastructure.

Throughout my career, I have consistently demonstrated my ability to drive IT and IS initiatives, ensuring alignment with organizational goals. I have a proven track record of providing reliable support services, optimizing system performance, and implementing robust solutions. With my comprehensive technical knowledge and project management skills, I am well-equipped to contribute to the success of IT projects and the overall efficiency of the organization.

As an Oracle Database Administrator (DBA), my responsibilities revolve around the effective management and administration of Oracle databases. This includes installing, configuring, and maintaining database software, ensuring optimal performance, security, and availability. I am proficient in managing database backups and recovery processes, implementing data integrity and security measures, and performing regular database monitoring and tuning. Additionally, I am experienced in troubleshooting and resolving database-related issues, conducting database upgrades and patching, and collaborating with developers and system administrators to optimize database performance within the broader IT infrastructure. With a strong understanding of Oracle database architecture and best practices, I strive to ensure the reliability, scalability, and efficiency of Oracle databases to support critical business operations.

• Optimized core processes to improve business performance and operational agility.

i) For Pipe Works, an Oracle 7.x database was utilized in conjunction with a D2k front end and Perl scripting to develop a comprehensive material handling system. ii) Theme Park Magic World in Dubai was brought to life using Oracle 7.x and VB, resulting in a dynamic and immersive experience for visitors. iii) Oracle 7.x and Visual Basic were employed in offshore development projects for power ventures in the US, including Redhills, Millennium, and Gregory. These initiatives contributed to the successful execution of these power projects.

In collaboration with Lurgi GMBH, a large-scale project was successfully completed, focusing on the implementation of Continuous Process Plants. This endeavor achieved a significant milestone in Asia by breaking records for non-stop running without any breakdown or downtime during the trial phase. The project also encompassed plant automation, where Programmable Logic Controllers were implemented in partnership with L&T. These controllers were deployed throughout the entire plant, including its second production line, further enhancing the efficiency and automation of operations.