Officer -QA

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

Job summary

Lupin in India seeks a Pharmacy graduate with 2-4 years of experience to ensure batch records compliance and adherence to SOPs on the shop floor.

You will perform in-process checks, sampling, line clearance, and monitor contamination risks while reviewing master batch and packing records in SAP.

The role involves investigations into product or system failures and ongoing training to maintain cGMP awareness.

Qualifications

• Graduation in Pharmacy is required.
• 2-4 years of experience in pharma manufacturing quality.
• Knowledge of cGMP and batch records.

Responsibilities

• Ensure SOPs and cGMP on the shop floor are followed.
• Perform line clearance to prevent mix-ups and contamination.
• Conduct in-process checks and sampling at manufacturing stages.
• Review master batch records and packing records in SAP.
• Participate in investigations related to product or system failures.
• Train technicians on cGMP requirements.

Skills

Batch records

Line clearance

In-process checks

cGMP compliance

SAP

Quality investigations

Education

Graduation in Pharmacy

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