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.
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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.
