Quality Assurance - IPQA Lead

Biological E; New Delhi; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Biological E is seeking a QA professional to provide line clearance and in-process QA oversight across manufacturing and packing operations in Delhi, India. The role ensures strict adherence to SOPs, BMRs/BPRs, and GMP/GDP standards while coordinating sampling, testing, and batch release activities.

The candidate will review manufacturing documentation, support audits, and lead quality investigations, CAPAs, and change controls.

Qualifications

• Experience with GMP/GDP requirements and manufacturing SOPs, BMRs, BPRs, and protocols.
• Ability to review and approve manufacturing documents and reports.
• Strong understanding of quality systems and regulatory expectations.

Responsibilities

• Provide line clearance and in-process QA oversight throughout manufacturing and packing operations.
• Ensure compliance with SOPs, BMRs, BPRs, protocols, GMP and GDP requirements.
• Perform and coordinate stage-wise sampling, finished-product, stability, cleaning, and control sample activities, including batch release in SAP.
• Review and approve BMRs, BPRs, protocols, SOPs, reports, logbooks, and manufacturing documents.
• Perform AQL inspections, control sample inspections, and prepare AQL trends.
• Monitor and review media fills, NVPC trends, critical alarms, audit trails, BMS reports, and sterilizer records.
• Manage visual inspection qualification, including defect sets, test sets, and inspector qualification.
• Assess manufacturing breakdowns, deviations, investigations, CAPAs, change controls, and market complaints for timely closure.
• Support gowning qualification, personnel training, and competency/qualification of manufacturing staff.
• Ensure timely identification and escalation of significant quality issues to senior management.
• Participate in regulatory and customer audits and implement audit remediation actions.
• Prepare and review CPV, APQR, AQL, and other quality-related reports and trends.
• Coordinate with cross-functional teams including RA to maintain compliant operations.
• Review and approve manufacturing staff job descriptions and related quality documentation.
• Act as Designee to the IPQA Lead when required.

Skills

QA oversight

GMP/GDP knowledge

Documentation review

Job description

• Provide line clearance and in-process QA oversight throughout manufacturing and packing operations.
• Ensure compliance with SOPs, BMRs, BPRs, protocols, GMP and GDP requirements.
• Perform and coordinate stage-wise sampling, finished-product, stability, cleaning, and control sample activities, including batch release in SAP.
• Review and approve BMRs, BPRs, protocols, SOPs, reports, logbooks, and manufacturing documents.
• Perform AQL inspections, control sample inspections, and prepare AQL trends.
• Monitor and review media fills, NVPC trends, critical alarms, audit trails, BMS reports, and sterilizer records.
• Manage visual inspection qualification, including defect sets, test sets, and inspector qualification.
• Assess manufacturing breakdowns, deviations, investigations, CAPAs, change controls, and market complaints for timely closure.
• Support gowning qualification, personnel training, and competency/qualification of manufacturing staff.
• Ensure timely identification and escalation of significant quality issues to senior management.
• Participate in regulatory and customer audits and implement audit remediation actions.
• Prepare and review CPV, APQR, AQL, and other quality-related reports and trends.
• Coordinate with cross-functional teams including RA to maintain compliant operations.
• Review and approve manufacturing staff job descriptions and related quality documentation.
• Act as Designee to the IPQA Lead when required.