Quality Assurance Specialist

Aodh Lifesciences; Hyderabad; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Aodh Lifesciences in Hyderabad seeks a QA professional with 1.5 to 4 years of quality assurance experience in pharmaceutical/life sciences. The role centers on document control, data integrity, and regulatory readiness under a RA-led framework.

You will enforce ALCOA+ across records, manage change control, and drive CAPA from deviations and audits while coordinating internal audits and ensuring audit-ready documentation for CTD submissions.

Qualifications

• 1.5 to 4 years' experience in quality assurance (pharmaceutical/life sciences).
• Experience with GxP documentation, audits, and CAPA processes.
• Familiarity with regulatory submissions and data integrity principles.

Responsibilities

• Act as the point of contact for QMS document initiation, review routing, and approvals.
• Enforce ALCOA+ principles across records and data packages.
• Manage Change Control evaluating process/method/equipment changes for QA impact.
• Initiate, track, and close CAPA from deviations, OOS/OOT events, or audits.
• Coordinate internal audits and generate audit reports; track closures.
• QC checks on technical documents for accuracy, traceability, and template adherence.
• Ensure audit-ready documentation with cross-references to source data and narratives.
• Support regulatory readiness of submission documents before packaging.

Skills

Quality assurance

GxP compliance

Documentation control

ALCOA+ data integrity

CAPA management

Internal audits

Regulatory readiness

Education

Bachelor's in Life Sciences/Pharma/Quality Assurance

Tools

Document management system

CAPA tracking software

Job description

About The Company

At Aodh Lifesciences, we are building a next-generation deep science drug development company focused on redefining respiratory drug delivery through a regulatory-driven approach. Our work integrates translational biology, microbiology, advanced formulation and device engineering, PBPK modelling, IVIVC modelling, and regulatory-grade data generation to develop targeted therapies designed to improve local efficacy while minimizing systemic exposure and addressing antimicrobial resistance.

We are looking for driven individuals who are curious, think deeply about the science, and are excited to take ownership in a zero-to-one environment, building not just products but a globally relevant, regulatory-grade R&D ecosystem from the ground up.

Key Responsibilities

• Act as the point of contact between all departments and the quality management system governing document initiation, review routing, and approval workflows.
• Issue documentation assignments to the appropriate departments based on document type, GxP classification, and quality risk level.
• Enforce ALCOA+ principles across all records, raw data packages, and derived documents; review laboratory records and analytical reports to confirm data integrity, in both physical and electronic forms
• Manage Change Control processes evaluating proposed changes to processes, methods, materials, or equipment for quality and regulatory impact prior to implementation.
• Initiate, track, and close Corrective and Preventive Actions (CAPA) arising from deviations, OOS/OOT events, non-conformances, or internal audit findings verifying root cause quality and closure effectiveness.
• Conduct or coordinate internal audits and self-inspection programs to assess GxP compliance across functions; prepare audit reports and track observation closures.
• Conduct QC checks on all technical documents prior to release: cross-reference verification, data consistency between source and narrative, citation accuracy, and template adherence.
• Maintain complete traceability of all documentation ensuring source data, derived narratives, and supporting records are cross-referenced and audit-ready at all times.
• Facilitate and document Management Review Meetings (MRM).
• Review regulatory readiness of submission documents received from R&D, formulation, analytical, and device engineering teams before submission packaging.
• Support CTD-level collation and compilation of source data into compliant regulatory narrative documents under RA leadership guidance on structure and applicable guidelines (ICH, CDSCO, FDA, EMA).
• Coordinate authoring assignments to appropriate departments based on document type; track revision cycles, due dates, and sign-off status.
• Consolidate review comments from cross-functional stakeholders, route to appropriate authors, and verify resolution before document finalization.
• Assist in preparation and quality review of deficiency responses to regulatory agency queries coordinating with SMEs to ensure responses are complete, traceable, and submission-ready.

Experience

1.5 to 4 years' experience in quality assurance (pharmaceutical/life sciences).