About the Role

Azurity is seeking a Manager to execute QA Operations internationally to ensure full compliance with US FDA, EU GMP, Health Canada, PIC/S and GDP regulations and guidelines. As part of these core responsibilities, this role will support Global Quality Operations including deviation/OOS assessment, CAPA management, change control, PQR reviews, product complaints, performance of vendor audits, and technical batch release, as applicable.

Key Responsibilities

- Execute QA oversight for assigned CMOs, 3PLs and other types of vendors based Internationally, including deviation/OOS assessment, change control, and CAPA evaluation.
- Perform technical documentation for batch disposition (e.g. batch record reviews, CoAs, deviation/OOS investigation reports, stability data) to support in-market product release.
- Ensure quality processes align with international standards and local market requirements.
- Collaborate with Supply Chain, Regulatory, Technical Operations, for the supply of medicinal products to the various markets.
- Manage assigned vendors for Quality Systems - deviation investigation, CAPAs, change control management, product quality reviews (PQRs), compliance risk assessment,



self-inspections, and Quality Technical Agreements.
- Support inspections from the local Health Authorities and follow-up actions.
- Support GMP/GDP audits of CMOs, 3PLs, and other vendors, if required.
- Participate in local risk management and escalation processes aligned with global procedures.
- Execute continuous improvement and training of QA personnel related to regulatory/compliance requirements.

Required Skills and Experience

- Minimum 5 years in pharmaceutical Quality Assurance / QA Operations (QC experience would be eligible)
- Previous experience in managing external pharmaceutical manufacturing partners (CMOs).
- Working knowledge of Veeva Quality Vault (Quality Management System) is beneficial.

Preferred Qualifications

- Degree in pharmacy, chemistry, or biology or any other related science background.

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Manager, QA Operations (Hyderabad)
🏢 Azurity Pharmaceuticals
📍 Hyderabad