Job Description
Designation: Quality Assurance Specialist
Location: Hyderabad (On-site)
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.
Role Summary
The Quality Assurance Specialist owns the quality lifecycle of all technical and scientific
documentation ensuring every record, data package, and authored deliverable meets
ALCOA+ principles, GxP requirements, and applicable regulatory standards. The role
enforces document integrity across the organization through rigorous QC, change
control, CAPA governance, and audit readiness. As a closely integrated secondary
function, the QA Specialist supports the Regulatory Affairs pipeline by providing
compliance oversight of CTD-bound documents, reviewing submission-ready packages,
and coordinating deficiency responses serving as the quality gate before any document
enters a regulatory submission.
Key Responsibilities
• Own and maintain the Document Management System (DMS) governing
document creation, version control, approval workflows, archival, and
retirement across all departments.
• Act as the single 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.
• 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; escalate
delays or scope gaps to the QA Manager or Head of RA.
• 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.
Qualification: 2–5 years’ experience in quality assurance (pharmaceutical/life sciences).
Freshers with relevant knowledge can also apply.
Education: M. Pharma — Pharmaceutics, Pharmaceutical Chemistry, QA,
Pharmaceutical Analysis, or Pharmacology