Manager, QA Operations

Azurity Pharmaceuticals; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Company pension

Job summary

Azurity Pharmaceuticals is seeking a Manager to execute QA Operations internationally to ensure full regulatory compliance and timely product release. You will oversee deviation/OOS assessments, CAPA management, change control, PQR reviews, and batch disposition documentation for in-market release.

The role requires 5+ years in QA/QA Operations, experience with CMOs, and familiarity with QMS tools like Veeva Quality Vault.

Qualifications

• Minimum 5 years in pharmaceutical QA/QA Operations (QC eligible).
• Experience managing external manufacturing partners (CMOs).
• Knowledge of Veeva Quality Vault (QMS) is a plus.

Responsibilities

• Oversee QA operations internationally to ensure FDA/EU/Health Canada/GDP compliance.
• Handle deviation/OOS assessment, CAPA management, change control, and PQR reviews.
• Review batch disposition documentation and CoAs for in-market release.
• Coordinate with Supply Chain, Regulatory, and Technical Ops for product supply.
• Manage vendor quality systems, audits, self-inspections, and QTA agreements.
• Support health authority inspections and post-inspection actions.
• Participate in risk management and global procedure alignment.
• Lead QA training to ensure regulatory/compliance competence.

Skills

Quality Assurance

CMO management

CAPA evaluation

Deviation/OOS assessment

GMP/GDP knowledge

Veeva QMS knowledge

Education

Pharmacy/Chemistry/Biology degree

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.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.