Site Quality Head

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 companys 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.