Azurity Pharmaceuticals - India
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 an Associate Director to manage 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
- Lead QA oversight for assigned CMOs, 3PLs and other types of vendors based Internationally, including deviation/OOS assessment, change control, and CAPA evaluation.
- Oversee 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.
- Oversee Quality Management System for assigned vendors: 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
- Conduct GMP/GDP audits of CMOs, 3PLs, and other vendors.
- Participate in local risk management and escalation processes aligned with global procedures.
- Lead continuous improvement and training of QA personnel related to regulatory/compliance requirements.
- Lead a team of QA Operations personnel.
Required Skills and Experience
- Minimum 10 years in pharmaceutical Quality Assurance / QA Operations (QC experience would be eligible)
- Previous experience in managing external pharmaceutical manufacturing partners (CMOs).
- Team management experience.
- 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.
To apply for this job please visit job-boards.greenhouse.io.
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Working in Hyderabad, Telangana
Hyderabad is the capital and largest city of the Indian state of Telangana. It occupies 650 km2 (250 sq mi) on the Deccan Plateau along the banks of the Musi River, in the northern part of South India. With an average altitude of 536 m (1,759 ft), much of Hyderabad is situated on hilly terrain around artificial lakes, including the Hussain Sagar lake, predating the city's founding, in the north of the city centre. According to the 2011 census of India, Hyderabad is the fourth-most populous city in India with a population of 6.9 million residents within the city limits, and has a population of
Telangana is a state in southern India on the Deccan Plateau bordering Maharashtra and Chhattisgarh to the north and Andhra Pradesh and Karnataka to the south. It is the eleventh largest and the twelfth most populated state of India. According to the Rigveda's Aitareya Brahmana, the region corresponding to Telangana has been inhabited by the Andhras since at least the 9th century BCE with the late
Source: Wikipedia (state)
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