Officer QA IPQA-Thol

Sr. No. Responsibilities

1.0 Line Clearance activity.

1.1 Line clearance of area and Equipments as per checklists of SOP at various stages of dispensing, manufacturing and packing activity.

2.0 In Process activity.

2.1 Approval of Specimens, In Process control as per mentioned in SOP and batch records at various stages of all dosage forms.

3.0 Monitoring of cGMP practices at shop floor.

4.0 Sampling Activity.

4.1 Sampling of in process bulk product, finished product, PV, CV samples, Wash water, Retain samples as per SOP/ protocol and registration sample as per RA request.

5.0 Verification of status labels on equipments and containers.

6.0 Verification of Documents.

6.1 Review of temperature, relative humidity and differential pressure records, Operational and Cleaning records and related documents.

7.0 Disposition of Raw material, Packing material, in process/ semi-finished and finished products.

8.0 Handling of raw material and packing material dispensing activity.

9.0 Handling of QMS related activities.

9.1 Initiation of Change Control Form, Deviation.

10.0 Review of Documents.

10.1 Review of batch manufacturing and batch packing records during batch processing and after completion of batch processing.

10.2 Review of Logbooks.

11.0 Annual Product Quality Review.

11.1 Collection of Data for APQR, Preparation of APQR.

12.0 Handling of Documents.

12.1 Numbering and Evaluation of Code to code, Plant to Plant, Wrong Punching, Transfer Posting, Breakdown Memo, Predictive Maintenance Format.

Quality Assurance