Manager - Quality Assurance

Monitor all cGMP activities at the site and facilitate regulatory inspection management, including tracking compliance actions from internal and customer audits. Draft and ensure timely inspection responses while monitoring CAPA timelines and collaborating with the corporate compliance group to implement global CAPA. Facilitate cross-functional investigation teams, support plant management of compliance activities, and provide oversight of quality outcomes from regulatory inspections and commitments. Perform gap assessments for 483s and warning letters, conduct self-inspections of quality systems, and educate staff to institutionalize a culture of quality. Review regulatory inspection observations to decide compliance strategy and provide input on major health authority inspections. Requires 13 to 15 years of experience; location Mohali.