Roles and Responsibilities :
Develop and implement production processes for bulk drug manufacturing, ensuring compliance with cGMP guidelines.
Conduct quality control testing of APIs, BMRs, and finished products to meet USFDA standards.
Collaborate with cross-functional teams to resolve product development, processing, and packaging issues.
Ensure timely delivery of high-quality products by monitoring production schedules and identifying improvements.
Implement and maintain effective quality management systems to ensure regulatory compliance.
Analyze production data to identify trends and prospects for process enhancements.
Job Requirements :
Solid understanding of cGMP regulations (USFDA) and GMP principles.
Experience with BMR preparation and review is required.
Knowledge of bulk drugs, CGMP, GMP, USFDA, API, and production processes is essential.
Ability to work collaboratively with cross-functional teams.
Possess robust analytical and problem-solving skills.
Demonstrate attention to detail and the ability to manage multiple tasks simultaneously.
📌 Production Chemist To Senior Executive Vadodara
🏢 Ami Lifesciences
📍 Vadodara
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