Job
Description
We are hiring for a Green Field Projects at Amneal , Ahmedabad. Following is the JD : Key Responsibilities : Lead QA operations related to Qualification & Validation, including Cleaning Validation, Process Performance Qualification (PPQ), and Computer System Validation (CSV). Develop and implement Validation Master Plans (VMP), Contamination Control Strategies, and Quality Risk Management (QRM) frameworks. Ensure qualification and validation of manufacturing equipment, utilities, and computerized systems to meet regulatory requirements. Drive regulatory inspection readiness, acting as SME for audits including USFDA, EMA, ANVISA, and WHO. Implement and optimize QMS using a risk-based approach, ensuring continuous monitoring and integration of compliance standards. Oversee execution of large-scale validation projects, such as Green Field Injectable facilities, and ensure regulatory approval readiness. Collaborate cross-functionally with Quality, Engineering, Production, and Regulatory Affairs teams for the successful and timely delivery of validation-related initiatives. Promote lean validation practices and continuous improvement strategies to enhance operational efficiency and regulatory compliance. Mentor, develop, and manage a high-performing QA validation team in a cross-cultural, fast-paced environment. Key Requirements : Education : Bachelors or Masters degree in Pharmacy, Chemistry, or related life sciences field. Experience : Minimum 15 years of experience in QA with strong specialization in Qualification & Validation within pharmaceutical manufacturing. Proven experience in injectable/sterile manufacturing environments is highly desirable. Hands-on experience in handling international regulatory audits and validations across FDA, EMA, and ANVISA-regulated markets. Technical Skills : Expertise in Cleaning Validation, PPQ, CSV, QRM, and VMP development. Strong command of GxP and global regulatory guidelines. Proficient in developing and managing QMS with focus on compliance and risk management. Leadership Skills : Demonstrated ability to lead cross-functional teams, influence stakeholders, and manage complex projects under tight timelines. Strong communication, decision-making, and coaching capabilities. Preferred Attributes : Green Field project experience, especially in injectables. Recognized as an SME in QA Validation. Familiarity with modern digital QA tools or systems is an added advantage. Interested candidate can share CV at bhuvneshwari.rathore@amneal.com
