Jubilant Pharmova Limited Hiring For Senior Manager/Manager – IT Application – CSV at Noida Full Time

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

Location- Greater Noida/Noida

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 metric.Manage projects from POC to design, deployment and rollout

Desirable 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.