Quality Assurance - IPQA Lead
Biological E Ltd. · Not specified · onsite · Posted 43d ago
Undisclosed13–16 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- 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.
Sourced from naukri
Skills
IPQASterileInjectablesQuality Assurance
About Biological E
Biological E Ltd.
Pharma
3.4k+
employees
1953
73 years old
Hyderabad/Secunderabad, Telangana
India
₹6.4L PA avg
Avg at Biological E
About
Leading Indian biopharma firm supplying vaccines to 130+ countries, known for producing over 2 billion COVID-19 doses and advancing global immunization efforts.
Industries
Pharma
Employee ratings
10 reviews
4.2/ 5
Culture
3.7
Career growth
3.6
Work-life
3.6
Employees rate it well for
Job Security44Overall Company42
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