Officer - Quality Assurance

Lupin; Sikkim; Remote; INR 600,000 - 900,000; Full time

Job summary

Lupin in India is seeking a Pharmacy graduate with 2-4 years of experience to join our Quality/Compliance team. You will ensure adherence to cGMP, SOPs, and batch records on the shop floor, and monitor line clearance to prevent contamination.

You will perform in-process checks at various manufacturing stages, sample materials as required, review master batch records and SAP entries, and support investigations related to product or system failures.

Qualifications

• Graduation in Pharmacy required.
• 2-4 years of experience in pharmaceutical manufacturing quality/compliance.
• Experience with cGMP, SOPs and SAP preferred.

Responsibilities

• Ensure line clearance and prevent cross-contamination on the shop floor.
• Perform in-process checks at different manufacturing stages.
• Sampling at various stages as required.
• Review master batch records and SAP entries; support investigations.

Skills

cGMP compliance

SOP adherence

Line clearance

In-process checks

Sampling

Batch records review

Process validation

Cleaning validation

Cleaning verification

Investigations

Education

Graduation in Pharmacy

Tools

SAP

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