Pradeep Kumar Email & Phone Number

Singapore

Bengaluru Area, India

 Fulfills job responsibilities as a Technical Representative of the Clinical Trials Supply Chain Service in its country, according to legal requirements. Maintain and assure compliance with current ICH, GXP, FDA Good Clinical Practices, ISO guidelines or any other as required in the position training program. Monitors the overall performance of staff members to ensure compliance with guidelines above. Ensures regulatory compliance standards are adhered to and that regulatory information is transferred appropriately to local staff and the corporate compliance team. Manages the restrictions (scope, cost, time, human resources, etc) in order to guarantee the depot complies with the expected performance indicators.  Is responsible for the local business development by periodically analyzing metrics(operational, occupancy, financial, etc.) and become the initiator of new projects whenever required. Reviews daily reporting and scheduling of hours worked for the staff. Provides consulting on pharmaceutical matters to various levels of personnel regarding pharmacy operations. Identifies and escalates to the Country Manager and the Human Resources any possible issue related to the depot staff that may impact the operational performance and/or working environment, such as change in local regulation, union representations, etc. Leads department meetings and in-service training for staff. Assures that all Customer’s concerns are duly assessed and follows-up the implementation of any preventive/corrective action. Responds to customer inquiries, requests and issues when situations demand escalation to a higher level of authority. Has deep knowledge about WC Depot infrastructure and equipment in order to facilitate the interaction with the local and global engineering and Technical QA team. Assists the Quality Assurance team in the internal audits performed by WC Quality Assurance  

India

Completely responsible for handling of IP and Cold Chain Management .Assure implementation of Protocol, SOP and Work instruction and to guarantee Good Documentation Practice.Participated in validation and calibration at the depot supporting suppliers and technical staffs.Managing hazardous material/dangerous goods.

Doctorate, Supply Chain Management

Master'S Degree, Biotechnology

Bachelor Of Pharmacy - Bpharm, Pharmacology

* B-Pharm -project work done on" Opthalmic film" and awarded Excellence