Co-ordination, facilitation, tracking and execution of activities related to training as a Departmental Training Administrator.
Troubleshooting and resolution of queries related to ASPIRE LMS.
Preparation of Risk Assessment Reports for Elemental Impurities in Drug Products per ICHQ3D for regulated Markets.
Preparation of Risk Assessment Protocols for Excipients used in Drug Products.
Preparation and Execution of protocol and reports as applicable.
Preparation of SOPs for quality systems.
Preparation of Protocol/Report of Nitrosamine Impurities.
Execution of Transportation Study of API per approved protocol.
Preparation of QMS trend data and report periodically as per the defined schedule.
IT Applications: Usage of Operation of SAP activities for all manufacturing , packing & QMS related T-Codes, Open Text, MS Office, Acrobat Reader, Departmental Drive, Skype, Outlook, Spring, HR Portal and ASPIRE Learning Management System.
Maintain Environment, Health and Safety system as per ISO 14001:2015 & ISO 45001:2018.
Any other responsibility assigned by Supervisor/Department Head.