Handle document of Packing and Inspection
Monitor all the activities related to packing and inspection.
Attend and ensure the training as per training schedule and TNI
Work according to standard operating procedures in sterile manufacturing department
Prepare, review, revise and control the Standard Operating Procedures of General Area in Sterile Manufacturing Department
Prepare BPR, Validate and calibrate all equipment and lines.
Record and check all the logbooks related to general area and equipment of packaging and inspection area
Train all the subordinates, technicians and operators of the department
Comply with cGMP, Good Document Practice and departmental discipline
Responsible to give proper planning to subordinates and ensure its implementation.
Responsible for preparation and review of Protocols and reports based on the requirements.
To have good communication skills to avoid misunderstanding.
Additional Responsibilities:
Responsible for preparation of packaging planning on monthly and daily as per the requirement and availability of materials.
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 to update on self-hygiene
Skills Required:
Packing - | Expert Level |
Visual Inspection - | Expert Level |
Dispensing - Understanding of Handling and dispensing procedure for different type of materials | Proficient Level |
Terminal Sterilization Process by Autoclave - | Basic Level |
GMP Compliance & Documentation - Adhering to Good Manufacturing Practices (GMP) and regulatory norms (USFDA, EU, WHO) | Proficient Level |
Understanding of Accurate and detailed record-keeping of every step in the injectable packing process. | Proficient Level |
Ensuring all packing equipments are calibrated and working within required parameters. | Proficient Level |
Identifying and resolving issues with packing equipment, ensuring minimal downtime. | Proficient Level |
Operating and handling packing machines to ensure smooth production of injectable products. | Proficient Level
Understanding of cleaning and sanitization of packing machines, controlled area, and aseptic zones as per SOPs. | Proficient Level |
Maintaining a sterile environment to avoid contamination during packing of injectables. | Proficient Level |
People Management | Proficient Level |
Leadership Skill | Proficient Level |
Trouble Shooting/ Problem solving skill | Proficient Level |
Education: B.Pharma/ M.Pharma/ M.Sc
Experience Required - Minimum 10 Years of experience in injectable packing
Note: Internal candidate who wants to apply for this job must have completed atleast 2 years in their existing job role.
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