Officer - Quality Assurance
Job Description
IPQA :
1. To give line clearance at relevant stages of process i.e. dispensing, manufacturing and packing stages.
2. To perform online in-process activities during manufacturing and packing area as per approved BMRs & BPRs and immediately reporting of any deviation to supervisor.
3. To collect and send samples (through LIMS/manually) i.e. routine batches analysis samples from respective stage, retest samples, process, Hold time study and cleaning validation sample as per respective sampling plan to quality control unit.
4. Execution of the process validation activities as per approved validation protocol.
5. To assist qualification activities as per respective protocol/instructions.
6. To collect and handed over the sample in control sample room.
7. Collection & submission of stability samples with stability request in QC department.
8. To ensure cGMP, GDP and GEP compliances during his shift in his respective area.
9. To review batch documents i.e. BMRs and BPRs online at each stage and completion of batch.
10. To perform daily, monthly and quarterly and/or as per requirement, verification/ calibration of respective IPQA instruments.
11. To monitor the effectiveness of CAPA taken relevant shop floor.
12. To verify the rejected consignment at warehouse.
13. To issue documents i.e. additional pages of BMRs, BPRs in shift as per requirements.
14. To perform the any other task/responsibility assigned by section in-charge.