Job Description

Job Context: Should work as India Pharma IT Business Partner within Jubilant Pharmova Ltd, collaborate with multiple internal and external stakeholders for driving IT projects for Pharma business and lead Global CSV/ IT Quality Operations. Education- Masters in Computer Science. Experience Range - 12 + Yrs Accountabilities Serve as the conduit between business functions and its representatives, and the shared functions in IT to ensure that appropriate services are delivered Lead the overall execution of multiple projects, including initiation, budgeting, scheduling, monitoring, and closure, lead site IT managers of India pharma business units Ensure vital communication within the project teams (meetings, minutes, action items) and coordinates / collaborates with other departments. Coordinate with internal resources, third parties/vendors, and multidisciplinary activities to ensure that the project deliverables are on-time, in-full, and in quantity. Track all the actions coming from the Project Management Office Responsible for weekly/monthly reports to CXOs by partnering with all the stakeholders to collect and analyze data and structure weekly/monthly reports for final submission. Strategically collaborate and co create programs along with BU Heads & their leadership team taking ownership of last mile delivery and benefit quantification. Identify operational risks and enable team to drive issues to resolution, balancing multiple priorities. Act as a catalyst for innovation by co- creating an impactful pipeline of use cases through internal ideation workshops and drive the governance agenda along with BU leadership to ensure delivery and value realization. Provide technical expertise to define approaches and execution of system validation activities in accordance with cGxP, CFR Parts 11, 210 & 211, Annex 11, GAMP5 and other applicable standards, regulations, procedures and industry trends such as risk-based CSA. Coordinate and collaborate with third-parties for the creation, execution and closure of validation deliverables for various cGxP IT solutions and projects Initiate and enforce necessary improvements and corrections to established systems and processes via standard procedures Work with Corporate Quality to ensure compliance with regulations. Keep appraised of the developments in relevant industry standards and the challenges in the Business Units to identify potential opportunities for improvement. Participate in external vendor audits relating to computerized systems. Assist in performing impact assessments and work with technical SMEs to close out IT related CAPAs and monitor commitment tracking items Participate in change control meetings and act as primary point of contact for core solution teams regarding change management, quality assurance and compliance management. Conduct evaluations of IT solutions for suitability per pharma regulatory and internal requirements, and articulate benefits and downsides of multiple solutions Work with project teams to select methods and techniques for obtaining desirable solutions for each project Coordinating software application implementations on time and within budget; identifying and mitigating risks that might impact the successful outcome of projects Identify opportunities, translate them into meaningful projects and perform project justification using both quantitative and qualitative metrics Manage projects from POC to design, deployment and rollout Desirable Experience. Lead Experience Digital and IT Program Management Experience Supervisory Experience Pharmaceutical Experience, US-FDA Regulated Industry Experience. Functional Skills. Knowhow of Pharma Regulated Applications, SAP, Cloud technologies, IT/OT convergence Must possess full fluency in MS Office (Word, Outlook, PowerPoint) with knowledge of using Power BI, Microsoft Project (MS Project/Primavera) to monitor, control, and provide overall visibility to the organization. Knowledge of manufacturing (process, equipment, facility, automation) & quality (GLP, cGMP, 21 CFR Part 11 validation, etc.). Good understanding of product development lifecycle. Knowledge of Quality Assurance, CAPA, Change Control, Document Control, Training Systems.

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