Job Description

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 opportunity 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.