Job Description

Division
ZHL DAMAN PLANT QA
Job posted on
Jan 17, 2026
Employee Type
C-C7-Confirmed-HO Staff
Experience range (Years)
3 years - 10 years

To ensure the procedure is followed at all the critical production stages to maintain the sterility of the components and products.




Perform IPQA activities in OSD & Injection department.




To monitor the aseptic practices during media fill run; to evaluate and suggest improvements in practice.




Responsible for quality oversight of personnel, process and practice to meet the cGMP and compliance requirement.




Responsible for reporting non-conformance to lead of the section.




To review the video CD for aseptic practices and sterility assurance.




To participate in the media fill failure and investigation as a part of investigation team and responsible for evaluating adequacy of derived root cause with proper scientific rationale and justification.




To perform below activities related to environment monitoring:
a) To expose plates of passive monitoring in aseptic as well as support area.
b) To perform active air sampling in aseptic as well as support area.
c) To perform surface monitoring in aseptic area.




To review the media fill protocol, BMR and all other documents associated with media fill and to ensure contemporaneous documentation.




To ensure line/equipment clearance for dispensing activity.




Responsible daily oversight of document destruction process.




To verify the potency calculation for the dispensed API.




To verify periodic calibration of balances and other instruments.




To ensure segregation of the rejected material and safe disposal of the same.




To ensure compliance to preventive maintenance/ calibration planner.




To verify qualification /validation activities of all production and Utility systems and continuous performance.




To provide information required for the Preparation of Annual Product Review with regards to Validation.




Sampling at different stages of Engineering Batch.




To review executed batch records and to release the batch along with necessary entries in SAP.




Responsible for stage wise review of electronic data parameters, review by exception and sign in MES wherever applicable.




To ensure submission of the samples to QC for analysis.




To review SOP related to manufacturing area and ensure compliance.




To review respective manufacturing log books (for e.g., area cleaning logbook, equipment usage logbook) and environmental monitoring records (for e.g., temperature and humidity logbook) and to ensure contemptuous documentation.




To review electronic records like PLC, SCADA, equipment printouts, audit trails, alarms and events as per site SOP.




To check the gowns used in the area are defect free and to ensure that gowning procedure is followed respective area wise entry/exit SOP.




To interact with Production on the non-conformance (if any) and discuss the corrective actions.




To evaluate and comment on change proposals initiated in the area of operation.




To support investigation of the deviation/incidences, non-conformances, market complaint, OOS (Phase II- Process Investigation) and to verify the CAPA proposed in the area of operation.




Review of departmental SOP's for verification of adequacy of the defined procedure and ensure compliance.




Monthly physical verification of stock of raw material against entries made in SAP.




Withdrawal of SFG, FG & Blending Sample as per SOP.