Job Title

About the Company - Ajanta Pharma is a specialty-focused, research-driven pharmaceutical company committed to delivering quality medicines across over 30 countries, including the US, Asia, Africa, and CIS regions. With a strong presence in branded generics, Ajanta is known for its innovative products, world-class manufacturing facilities, and a culture of excellence. The company's mission is to provide quality pharmaceutical products with a commitment to excellence and innovation.About the Role - Ajanta Pharma is seeking a Site Quality Head (Sr. General Manager – Quality) to oversee the Quality Assurance and Quality Control functions at their formulation plant in Guwahati. The ideal candidate will have experience in leading quality systems and ensuring regulatory compliance.Responsibilities- Lead the entire Quality function (QA & QC) at the Guwahati site, ensuring compliance with internal standards and external regulatory requirements. - Develop and implement robust Quality Systems in line with cGMP, GxP, and applicable regulatory guidelines (e.g., WHO, CDSCO, etc.). - Oversee laboratory operations, analytical testing, stability studies, and data integrity in Quality Control. - Drive continuous improvement initiatives in quality systems, processes, and documentation. - Ensure regulatory readiness of the site for domestic and future export markets, including USFDA, EU, TGA, etc. - Provide leadership in handling regulatory audits, customer inspections, and internal quality audits. - Mentor and guide the QA/QC teams, building a culture of quality, accountability, and excellence. - Collaborate with cross-functional teams (Production, Engineering, Regulatory, etc.) for seamless quality integration. - Ensure timely investigation and closure of deviations, OOS/OOT results, and CAPA implementation.Required Skills- Strong leadership and communication skills. - Experience in developing and implementing quality systems. - Knowledge of regulatory guidelines and requirements. - Ability to mentor and guide teams towards a culture of quality and excellence.Preferred Skills- Experience in handling regulatory audits and inspections. - Knowledge of international regulatory requirements (USFDA, EU, TGA, etc.). - Experience in continuous improvement initiatives in quality systems.