Creation and Review of Master documents: Specification, Standard testing procedure, analysis and general procedure, raw materials and finished products in LIMS.
Initiation and tracking of QMS events and evaluation of impact on Master documents.
Revision of Master documents: SPEC, STPs and general procedure based on the approved change control.
Ensuring RFT in documents by creating error free documents.
Implementation of Pharmacopeial changes and source change document.
Review and tracking of DMF in PLM and preparation of Master documents based on AMV/AMT/Evaluation report.
Handling of LIMS master data activities and resolving of SAP/LIMS related queries.
Creation and revision of Raw Data Sheet.
Preparation of Residual solvents justification reports.
Harmonization of SPEC/STP/RDS for API and Excipients.
Maintaining track wise discipline by tracking pending tasks, closure of quality events.
Ensuring compliance / completeness for applicable Logbook/Register.
Creation of harmonized templates for Spec/STP/RDS.
Tracking of CAPA assigned and checking on the task applicability to Master data team based on RCI.
Implementation of previous learning / improvement points to the upcoming projects / during subsequent revision of Spec/STP/RDS.