Manish Bhardwaj

• System Manager of RIMS solution (REGISTER) and for GriTS system. • Change and Release manager for regulatory changes, qualification responsible. • Business and Vendor coordinator, Key person in road map and system upgrade and retirement strategy. • Responsible for close collaboration between different teams and conducting review meetings against delivery. • Project manager for upgrade/infrastructure related releases or Tech-refresh.

• IT Lead for R&D Regulatory applications in RIM (Liquent Insight) and Submission module (ectd publisher & express). • Project lead for regulatory in-house applications in scope of Application Life cycle management. • ITSM, processes management via different tools like Remedy, Pandora. • Vendor, Business coordination for efficient Client delivery.

• Execution of service delivery & performance management of Research, Regulatory R&D applications. • Service Integration with active involvement of vendors, support, business, IT & other stakeholders. • Process & Risks & Quality Control, IT Audit and Escalations Management, GDPR Assessment, Service reporting (MSR) for GRED, GRA • Application Life Cycle management to ensure technological readiness adherence to service value for client. • Project planning, risk assessments, requirements discovery.

• SME for RIMS(Liquent Insight Manager) , agEncoder , Mosaic(Titian Compound Logistics) , Open-lab , Simcyp , Empower in R&D Portfolio. • Experienced in functioning of IT operations control tool like HPSM/SNOW, SCDB, CMDB etc. • Incident & Problem & Change Management against SLA targets. • Qualification documentation expertise like QP, TS, IQP, IQR ,FIT and CAPA etc. • Deep business process understanding in delivering required Analytical/Data based on SQL scripts.

Focus: Hardware and Communication systems