Officer, Analytical R&D at Amneal Pharmaceuticals in India, IN

Should have minimum 2 years of experience in same function - Preparative HPLC

Description:

Responsible for ensuring the accuracy and reliability of laboratory instruments through regular calibration and preventive maintenance. This role involves the daily verification of key instruments, such as balances, pH meters, and Milli-Q water systems, as well as monitoring environmental conditions like temperature. The analyst will perform chemical and instrumental analyses (including Wet Chemistry, HPLC, GC, GC-MS, LC-MS, ICP-MS, XRD, AAS, etc.) to support R&D and production processes, ensuring product quality at various stages of development and manufacturing. Additionally, the role involves the preparation of impurity standards, working standards, and primary reference standards, as well as maintaining compliance with cGMP guidelines and ensuring data integrity in all laboratory activities.

Essential Functions:

• Perform the calibration and preventive maintenance of the instruments as per the respective schedules.
• Perform the determination of KF factor, Daily verification of Balances, pH meter, Milli-Q water system, Hygro meters, Refrigerator temperature monitoring .
• Perform the in-process/ intermediate/ finished products analysis by Wet/ Chromatography techniques for R&D/ Plant support.
• Chemical/ instrument analysis (i.e. Wet/ HPLC/ GC/ GC-MS/ LC-MS/ ICP-MS/ XRD/ AAS/ ICP-MS, etc.)
• Perform the Impurity standard/ working standard/ primary reference standards
• To maintain cGMP and Data integrity.

Additional Responsibilities:

• Activities other than the defined in the Job Responsibility are to be done, as per the requirement of HOD

Qualifications

Education:

• Bachelors Degree (BA/BS) B. Sc - Required
• Bachelors Degree (BA/BS) B. Pharma - Preferred
• Master Degree (MS/MA) M. Sc - Preferred
• Master Degree (MS/MA) M. Pharma - Preferred

Experience:

• 3 years or more in 3-8 Yrs

Skills:

• Calibration & Preventive Maintenance - Intermediate
• Instrument Verification & Monitoring - Advanced
• In-Process & Product Analysis - Advanced
• Chemical & Instrumental Analysis - Advanced
• Standard Preparation - Intermediate
• cGMP & Data Integrity Compliance - Intermediate

Specialized Knowledge: Licenses: