Description The role involves ensuring CGMP compliance and supervising lyophilizer activities in manufacturing area Additionally the position requires reviewing and maintaining online documents Essential Functions To plan line wise activity as per production schedule Person shall be responsible for operation and handling of the general area To follow SOPs and minimize the deviations To follow GMP GDP Data Integrity as per respective SOP To work with the GMP and compliance in manufacturing process To maintain cleanroom with define cleaning frequency To Report if abnormality Deviation observed to immediate supervisor To complete the short term and long-term goals objective as set by H O D To ensure timely execution of batch manufacturing plan To control the rejection at various stages of manufacturing To review and review document of all operations To handle and monitoring and troubleshooting of Lyophilizer ALUS Autoclaves and general area activities Additional Responsibilities Activities other than defined in the Job responsibility are to be done as per the requirement of HOD by following HODs instruction and guidance To perform aseptic behaviour practice monitoring of operators while working inside aseptic process area during each aseptic batch GMP batch as per SOP Education Bachelors Degree BA BS B Sc - Required Bachelors Degree BA BS B Pharm - Required Master Degree MS MA M Sc - Preferred Master Degree MS MA M Pharm - Preferred Experience 3 years or more in 3 - 6 Yrs Skills Good Manufacturing Practice - Proficient Batch Record Review - Proficient Document Review - Proficient Equipment and Process Validation - Proficient Deviation Management - Proficient Compliance and Regulatory Knowledge - Proficient Internal Audits and Inspections - Proficient cGMP and Compliance Review - Proficient Manufacturing Activity Supervision - Proficient IPQA Instrument Calibration - Proficient Specialized Knowledge Licenses Amneal is an equal chance employer We do not discriminate based on caste religion gender disability or any other legally protected status We believe in fostering a workplace that values diversity and inclusion