Executive - Quality Assurance

Lupin Ltd; Pune District; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Lupin Ltd in Pune, Maharashtra, is seeking a Quality Assurance/Regulatory professional with 3–5 years of experience to oversee GMP compliance and CAPA finalization at the DS manufacturing and warehouse facilities.

You will review master documents, batch processing records, and SOPs, coordinate APQR data compilation, and ensure validation activities follow approved protocols.

Qualifications

• 3–5 years of relevant experience.
• Masters in Biotechnology.
• Knowledge of GMP and regulatory requirements.
• Experience with APQR data compilation and preparation.
• Review of batch processing records and dispatch records.

Responsibilities

• Visiting DS manufacturing and warehouse facilities to ensure GMP compliance and adherence to regulatory requirements.
• Participate in manufacturing investigations and CAPA finalization.
• Prepare and review risk assessments and mitigation plans.
• Ensure process and cleaning validation activities follow approved protocols.
• Review master documents (study protocol, BPR, MFR, etc.).
• Review executed Batch Processing Records for Batch Release and batch dispatch verification.
• Coordinate APQR data compilation and APQR preparation.
• Prepare and review Quality System SOPs and related documents.
• Review SOPs as per GMP requirements across departments.

Skills

GMP compliance

Regulatory requirements

CAPA coordination

Risk assessment

Education

Masters in Biotechnology

Tools

QMS software

Job description

• Visiting to DS manufacturing and warehouse facility to ensure that activities are being carried out by following GMP requirements, Regulatory requirement and as per approved procedures.
• To participate in the manufacturing investigation and CAPA finalization activity.
• Preparation and review the Risk Assessment and Mitigation Plan.
• Ensure that process and cleaning validation activities are being carried out by following approved protocols.
• Review of master document like study protocol, BPR, MFR etc.
• Review of executed Batch Processing Records for Batch Release.
• Review of Batch Dispatch Record and verification of dispatch activities in warehouse.
• Overall coordination for the APQR data compilation and APQR preparation activity.
• Preparation and review of Quality System SOPs & documents.
• Review of SOPs as per GMP requirements for all departments.

Date: Aug 12, 2026

Location: Pune Biotech, MH, IN

Company: Lupin

Job Description

• Visiting to DS manufacturing and warehouse facility to ensure that activities are being carried out by following GMP requirements, Regulatory requirement and as per approved procedures.
• To participate in the manufacturing investigation and CAPA finalization activity.
• Preparation and review the Risk Assessment and Mitigation Plan.
• Ensure that process and cleaning validation activities are being carried out by following approved protocols.
• Review of master document like study protocol, BPR, MFR etc.
• Review of executed Batch Processing Records for Batch Release.
• Review of Batch Dispatch Record and verification of dispatch activities in warehouse.
• Overall coordination for the APQR data compilation and APQR preparation activity.
• Preparation and review of Quality System SOPs & documents.
• Review of SOPs as per GMP requirements for all departments.

Work Experience

3 to 5 Years

Education

Masters in Biotechnology

Job Description

• Visiting to DS manufacturing and warehouse facility to ensure that activities are being carried out by following GMP requirements, Regulatory requirement and as per approved procedures.
• To participate in the manufacturing investigation and CAPA finalization activity.
• Preparation and review the Risk Assessment and Mitigation Plan.
• Ensure that process and cleaning validation activities are being carried out by following approved protocols.
• Review of master document like study protocol, BPR, MFR etc.
• Review of executed Batch Processing Records for Batch Release.
• Review of Batch Dispatch Record and verification of dispatch activities in warehouse.
• Overall coordination for the APQR data compilation and APQR preparation activity.
• Preparation and review of Quality System SOPs & documents.
• Review of SOPs as per GMP requirements for all departments.

Work Experience

3 to 5 Years

Education

Masters in Biotechnology