Job 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.