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
Handle document of Packing and Inspection
Monitor all the activities related to packing and inspection
Responsible for line clearance activity before commencing the operations
Responsible to follow the preventive maintenance schedule of machine
Responsible for cleaning and sanitization of visual inspection and Packing area.
Responsible to operate the machines .
Responsible to fill the log of general area as per SOP and work execution. Responsible to follow cGMP, GDP, and discipline in the department and to ensure that all employees follow the same.
Responsible to ensure that all equipment’s and lines are in validated and calibrated status.
Responsible to prepare daily production report as per the production achieved.
Responsible for preparation of production planning on monthly and daily as per the requirement and availability of materials.
Responsible for the handling of change control, deviations, CAPA, investigation etc.
Responsible for document management like BMRs, BPRs, master SOPs etc..
Responsible for preparation and review of protocols and reports based on the requirements.
Responsible for preparation and review of protocols and reports based on the requirements.
Responsible for preparation, review, revision, control, and implementation of standard operating procedures of sterile manufacturing department.
Responsible for line clearance activity before commencing the operations like manufacturing, Sterilization, filling etc..
Responsible to check that all the records and logbooks related to manufacturing, filling, garment washing and drying & sterilization of equipment’s .
Skills:
Adhering to Good Manufacturing Practices (GMP) and regulatory norms (USFDA, EU, WHO).
Completing BMRs/BPRs accurately.
Understanding of deviations, change control, and CAPA.
Performing efficient changeovers between different products, batch sizes, or formats.
Installing and adjusting forming/sealing materials, dies, and feeders.
Understanding of tooling parts for blisters, bottles, and cartons
ITI / B.Sc / Diploma
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Amneal India is a pharmaceutical company focused on developing, manufacturing, and marketing high-quality generic and specialty pharmaceutical products.