Deputy Manager- Corporate Quality Assurance

As a Corporate Quality Assurance (QA) professional at Alembic Pharmaceuticals in Mumbai, your primary responsibility will be to ensure the effective implementation of Quality Management System (QMS), adherence to regulatory standards, efficient vendor management, and maintenance of product quality standards across various sites. Your key responsibilities will include managing QMS processes such as deviations, change control, investigations, and Corrective and Preventive Actions (CAPA). You will be entrusted with handling FDA and market complaints, ensuring their timely closure. Additionally, you will oversee the qualification/requalification of vendors for raw materials and packaging materials, as well as address any vendor-related complaints. You will be required to review laboratory QA compliance issues like Out of Specification (OOS) and Out of Trend (OOT) results, oversee technology transfer activities, and ensure the accuracy of product documentation. Furthermore, you will play a crucial role in supporting regulatory audits and ensuring compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP). To excel in this role, you should possess a Bachelor's or Master's degree in Pharmacy (B. Pharm / M. Pharm) and have a minimum of 12 years of experience in pharmaceutical Quality Assurance, with a preference for exposure to corporate QA and QMS. A strong understanding of GMP standards, QMS principles, vendor management practices, and regulatory requirements is essential. Effective communication skills, proficient documentation abilities, and the aptitude for cross-functional coordination are also key requirements for this position. Your top skills should include expertise in Quality Management System (QMS), GMP Compliance, Corrective and Preventive Actions (CAPA), Vendor Management, and the ability to handle Regulatory Audits effectively.,