Planning and analysis monitoring of Raw material/ Retest material and interaction with Production and Ware house Department.
Monitoring of volumetric solution and general reagents including documentation as per respective SOP.
To participate in the laboratory failure investigation / OOS / OOT/ Unplanned Deviation /Lab event, root cause identification and its appropriate corrective action, correctiveness of Hypothesis performed, correctiveness of Impact analysis, verification of implementation of effectiveness of CAPA in QC Dept.
Planning and monitoring of sampling activity carried out at Dadra-I and Dadra-II.
Monitoring of Control sample and Out lab testing Activity.
Evaluation and implementation of Pharmacopoeial changes.
Planning of analysis for Working Standard.
Planning and monitoring of Vendor sample analysis.
Responsible and accountable for sample management in the Raw Material Material section.
Handling of QMS activity in trackwise system.
To execute the Gap Assessment related to Raw Material section.
Effective monitoring of RM section analyst productivity as per business requirement.
To conduct training as per need based on CAPA/ OOS/ OOT/ Lab event and as per revised or new SOP.
Co-ordination for document submission required by RA.
To impart training to RM Section analyst related to method and techniques provided in ATP.
To provide the inputs required for weekly/ monthly report preparation.
To report immediately if any abnormalities observed during analysis of RM section.
To ensure availability of column, reagent, working standard, reference standard, impurity standard for Raw material analysis.
To ensure the revision of SOP, Specification, ATP and Template required for RM section.
To ensure the effective cleaning procedure is being followed in Sampling and Sampling devices at Dadra-I and Dadra-II.
To track and monitor compliance related to RM section.
To monitor cleaning and upkeep of QC laboratory.
Participation in review & approve of SOP in EDMS.
To ensure laboratory cleanliness and orderliness.
To ensure the laboratory safety and personal hygiene in lab.
To check & follow the GLP standard in the laboratory
To follow GDP and GMP requirements on the routine basis
To follow and ensure the compliance related to Data Integrity.
EDMS forms Reconciliation:
Track, Monitor and reconcile EDMS forms before it's due date.
Take extension of Forms due for retrieval in EDMS in case if activity not completed
To perform any other additional activity assigned by Department head.
