Officer /Sr. Officer - Quality Assurance (API)

Role & responsibilities

1) He/ She should be aware with cGMP / WHO-GMP and US-FDA guidelines.

2) To ensure that all activities specified in the Quality Plan are satisfactorily completed.

3) To identify and report non-conforming Raw Materials, Intermediates and Finished Goods during inspection and generate NCRD report.

4) To allocate Lot No. to approved, finished goods and maintain records and inform the concerned department.

5) To carry out sampling of all incoming raw materials, Intermediates, Packing Materials and Finished goods.

6) To maintain records of analysis, allocation of the Finished Goods.

7) To prepare reagents and standardization and standardization of Test Methods.

8) To identify and maintain approved finished goods samples.

9) To allocate the approved Lot No. to finished goods and intimate the concerned department.

10) To take sample of Raw Materials, Packing Materials, Intermediates and Finished Goods and maintain their record.

11) To handle Calibration and validation procedure of latest CFR compliant instruments like, FTIR, HPLC, GCHS, AAS, & UV/ Vis CFR compliant spectrophotometer along with testing of various samples.

12) Testing of samples of Air and Effluent.

13) To carry out development work related to Plant.

14) To carry out testing of SRCD and CME.

15) To maintain statistical data of quality.

16) To assist Q.C./QA In-Charge / Unit Head in coordinating inspection job by clients .

17) To send samples to Marketing Department as per requirement.

18) To maintain ISO system and maintain Quality Records.

19) To comply with the DMF requirements & to prepare required documentation in consultation with QC/QA In-Charge.

20) To comply with Schedule M requirements & to prepare required documentation in consultation with QC/QA In-Charge.