Job Description

Description:

The role involves ensuring CGMP compliance and supervising Filling & sealing activities in manufacturing area. Additionally, the position requires reviewing and maintaining online documents.

Essential Functions:

Responsible for document management like BMRs, BPRs, master SOPs etc.. Responsible for preparation & review of the master documents of production. Responsible to ensure UAF working in area. Responsible for the handling of change control, deviations, investigation & CAPA, etc. Responsible for line clearance activity before commencing the operations. Responsible to check that all the records and logbooks related to manufacturing, Sterilization, washing and sterilization of equipment's. Responsible for preparation, review, revision, control, and implementation of standard operating procedures of sterile manufacturing department. Responsible to ensure cleaning and sanitization of General, Controlled & Aseptic area. Inform immediately to department functional head for any observation/disturbance with respect to documents and machines found in area. Responsible for monitoring all the activities related to General, Control & Aseptic area.

Additional Responsibilities:

Responsible to give training to all the subordinates, technicians, and operators of the department. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance. Responsible for self-hygiene. Responsible to attend the training as per schedule and to ensure the training and work as per TNI. To follow the cGMP, Good Document Practice, and discipline in the department.

Education:

Bachelors Degree B. Pharm - Preferred Master Degree (MS/MA) M. Pharm - Preferred

Experience:

5 years or more in 5 - 8 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.