QA Officer

Job Responsibilities:

1. Documentation cell management

1. Retrieval, archival, storage, destruction of master documents.

2. Issuance of various formats, data sheets, protocols as per intimation.

3. Issuance and archival of Batch records.

4. Naming, numbering and securing data files physically and digitally.

2. APQR drafting -

1. To compile batch wise data in approved formats for APQR preparation.

2. Submit draft to the higher ranks for review in timely manner.

3. Control Sample management -

1. Follow respective SOP and archive, label, store, destruct control samples of finished product and raw materials.

2. Follow control sample withdrawal procedure as per SOP.

3. Perform periodic visual inspection of control samples.

4. Daily environmental monitoring in control sample storage area.

4. Stability sample management -

1. Follow respective SOPs and archive, label, store and destruct stability samples as per SOP.

2. Timely submit samples to QC for analysis

3. Retrieve QC analytical data for completed analysis of stability samples.

4. Prepare summary report and send it for review.

5. Daily monitoring of stability chambers and follow data backup procedure.

6. Take daily temperature monitoring printouts from software.