Executive - QA

Lupin; Sikkim; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Lupin in India is seeking a quality compliance professional to oversee Batch records compliance, SOP adherence, and cGMP requirements on the shop floor. You will perform in-process checks, sampling, and batch release support, ensuring no contamination and line clearance across manufacturing stages.

The role involves QA/IPQA activities, CAPA handling, self-inspection coordination, and ongoing cGMP awareness training for technicians, with involvement in process validation and calibration

Job description

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 execution of Qualification and calibration activity.

Periodic review and preparation of APQR.

Handling of CAPA, Change controls, OOS, OOT, Laboratory Incidence, Market complaint & Deviations through QAMS.

Co-ordination & execution of Self Inspection and compilation of self-inspection observations.

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.

Active Participation in Batch Release Activity.

Active participations in all the IPQA activities.