Officer

Lupin; Sikkim; On-site; INR 400,000 - 700,000; Full time

Job summary

Lupin in India is hiring for a Pharmacy graduate to ensure cGMP compliance and batch record integrity on the shop floor. You will perform line clearance, in-process checks, sampling, and participate in investigations to prevent quality failures.

The role requires 2-4 years of experience in pharmaceutical manufacturing, with hands-on validation and SAP documentation. Training on SOPs and cGMP is part of the job, offering growth in quality assurance.

Qualifications

• Experience ensuring batch records compliance and cGMP on the shop floor.
• Conduct line clearance to prevent mix-ups and contamination.
• Perform in-process checks at various manufacturing stages.
• Sampling at different stages as required.
• Review batch records to enable timely release.
• Prepare, execute and compile process validation and cleaning validation.
• Review master batch and packing records in SAP.
• Participate in investigations related to product or system failures.
• Train technicians on cGMP requirements.

Responsibilities

• Ensure SOPs and cGMP compliance on the shop floor.
• Perform line clearance and continuous monitoring of processes.
• Carry out in-process checks across production stages.
• Sample products as required and at specified stages.

Skills

Batch record compliance

cGMP knowledge

Line clearance

In-process checks

Sampling

Process validation

Cleaning validation

Investigation skills

Education

Graduation in Pharmacy

Tools

SAP

Job description

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.

Work Experience

2-4 years

Education

Graduation in Pharmacy