Officer – Quality Assurance

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

Job summary

Lupin in Pune seeks a QA/Validation professional to oversee GMP-compliant manufacturing activities at the DS facility. You will participate in CAPA investigations, prepare risk assessments, and ensure adherence to approved procedures.

You will review master documents and batch records, support process and cleaning validations, and coordinate APQR data compilation, all while aligning with regulatory requirements and quality systems across departments.

Qualifications

• Masters degree in biotechnology or biotechnology.
• Post graduation in biopharmaceutics or pharmacy.
• Strategic agility and customer-centric approach.

Responsibilities

• Visiting to DS manufacturing and warehouse facility to ensure GMP compliance and regulatory adherence.
• Participate in manufacturing investigations and CAPA finalization activities.
• Prepare and review Risk Assessment and Mitigation Plans.
• Ensure that process and cleaning validation activities follow approved protocols.
• Review master documents such as study protocol, BPR, MFR, etc.
• Review executed Batch Processing Records for Batch Release.
• Review Batch Dispatch Records and verify dispatch activities in warehouse.
• Coordinate APQR data compilation and APQR preparation activity.
• Prepare and review Quality System SOPs and documents.
• Review SOPs as per GMP requirements for all departments.

Education

Masters in Biotechnology or Biotechnology

Post Graduation in Biopharmaceutics or Pharmacy

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

1- 3 YEARS

Education

Masters in Biotechnology or Biotechnology

Post Graduation in Biopharmaceutics or Pharmacy

1. Strategic Agility

3. Customer Centricity

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