Officer -QA

Lupin; Sikkim; On-site; INR 420,000 - 660,000; Full time

Job summary

Lupin in Sikkim is seeking an Officer -QA to ensure batch records compliance and adherence to cGMP in manufacturing. The role focuses on line clearance, process monitoring, sampling and SAP-based documentation to support timely release of products.

The candidate will train technicians on SOPs, participate in investigations related to product or system failures, and contribute to ongoing validation and quality assurance activities on the shop floor.

Qualifications

• Compliance with batch records and cGMP requirements.
• Ensure SOPs are followed and shop floor is compliant.
• Conduct line clearance and in-process checks at manufacturing stages.
• Perform sampling and stage-wise review of records for timely release.
• Contribute to process validation, cleaning validation and verification.

Responsibilities

• Adhere to batch records and cGMP requirements across batches.
• Monitor line clearance and prevent contamination during manufacturing.
• Perform in-process checks at different stages of production.
• Carry out sampling as required and review master batch records in SAP.
• Investigate product/system failures and participate in CAPA efforts.

Skills

Line Clearance

In-process Checks

Sampling

cGMP awareness

SOP training

Tools

SAP

Job description

Date: Aug 24, 2026

Officer -QA

Location: Sikkim, SK, IN

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 investigation related to product / system failure.

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