Responsible for Analyst qualification & QC employee training.
Responsible for Preparation and review of Documents like Specification, STPs, TDS, SOP, COA. MTP, MVP, MVR, MTR.
Responsible for Review of analytical data for routine samples (in process samples, DS, DP release and stability samples) method transfer and method validation.
Responsible for management of reference standard and material indenting in QC.
Responsible for Co-ordination with vendor for external calibration and with QC personnel for in- house calibration and verification of laboratory instruments.
Responsible for maintenance and management of laboratory equipment and instruments.
Responsible for managing method validation and method transfer activities.
Responsible for initiation and investigation of incident, deviations, change control, OOS, CAPA and OOT.
Responsible for analysis planning of DS, DP, Stability and protocol-based samples.
