About The Comapny

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 setting, 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).

Education: M.Pharm graduates specialising in Pharmaceutics, Pharmaceutical Chemistry, Quality Assurance, Pharmaceutical Analysis or Pharmacology; B.Pharm and other relevant Life Sciences graduates are also eligible.

📌 Quality Assurance Specialist (Hyderabad)
🏢 Aodh Lifesciences
📍 Hyderabad