Manager, QA Operations

RXinsider LTD.; Hyderabad; On-site; INR 3,000,000 - 5,500,000; Full time

Job summary

Azurity Pharmaceuticals 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. The role includes deviation/OOS assessment, CAPA management, change control, PQR reviews, product complaints, and vendor audits to support global product release.

Collaborate with Supply Chain, Regulatory, and Technical Operations to ensure quality across markets.

Qualifications

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

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.

Education

Pharmacy / Chemistry / Biology degree

Tools

Veeva Quality Vault

Job description

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

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.