Sikkim Officer QA SK

Compliance to the instructions given in Batch records of various products.

Ensuring the compliance of the SOPs and cGMP requirements at shop floor.

Ensuring no mix-ups, contamination and cross contamination of the products during all stages of manufacturing means of “Line Clearance” and continuous monitoring the process.

Performing “In-process Checks” at different stages of manufacturing for various products and ensuring the compliance.

“Sampling” at different stage of manufacturing or as per the requirement.

Stage wise review of batch records and compliances if any, to facilitate timely release.

Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification.

Review of master batch manufacturing record and batch packing record in SAP.

Active participation in investigation related to product / system failure.

Ensuring the awareness of cGMP and its requirement to the technicians/concerns through continuous interaction/SOP training.