1. To perform line clearance activity at the relevant stages of the process i.e. dispensing, manufacturing, and packing.
2. To perform online in-process activities during manufacturing and packing activities, adhering to the approved BMR/BPR & SOP’s and immediate reporting of any deviation from approved procedure to the supervisor.
3. Responsible for sampling activity and send samples (either through LIMS or manually) as per the respective sampling plan to the quality control unit for routine batch analysis from the respective stage, retest samples, process validation samples, hold time study samples, and cleaning validation samples.
4. To perform AQL activity at core/coated stage of products.
5. Execution of the process validation activities in accordance with the approved validation protocol.
6. To assist qualification activities as per respective protocol.
7. To collect control samples and handing them over to the control sample room.
8. Responsible for collection and submission of stability samples in QC department.
9. Responsible for ensuring cGMP,
GDP and GEP compliances during his shift in the respective area.
10. Responsible for reviewing batch documents i.e. BMRs and BPRs, after completion of each stage.
11. To perform release & closure comments for breakdown notifications in SAP system or on manual request ensuring proper impact assessment for the raised breakdown.
12. To approve the additional packing material request in SAP system or on manual request.
13. Responsible for performing daily, monthly and quarterly and/or as-needed verification/ calibration of respective IPQA instruments.
14. To monitor the effectiveness of CAPA taken relevant to the shop floor activity/process.
15. To verify the rejected consignment at warehouse.
16. To issue documents i.e. additional pages of BMRs and BPRs during shift as per the requirements.
17. Responsible to perform all activities & ensure the compliance of documents w.r.t. valuable documentation practices & DI policy.
18.