Operator

• To follow proper gowning / De-gowning procedure as per SOP.
• To follow all respective SOPs & BMR procedure in the department and during operation.
• To do the cleaning of Capsule filling machine, Shorter, Polishing machine, metal detector, check weigher, inspection machine and its cubicle as per SOP.
• To check and ensure the cleanliness of Capsule cubicle, equipment and environmental Condition (Eg:- tempreture,RH and pressure differential) within specified limit before Start and during Capsule filling process.
• To check and ensure proper operation of the capsule filling machine in Capsule area.
• To carry out in-process checks during Capsule filling operations as per MMD I.
• To manufacturing the product on time which complies the regulatory and marketing requirement.
• To monitor the capsule filling machine and operation without affecting Quality of product.
• To maintain all the log books & records where ever necessary.
• To check and ensure proper labelling of equipment, area and product in manufacturing area.
• To ensure that proper maintenance and safety of person and equipment’s.
  

Responsibilities

• To follow the departmental SOP, s as per GMP requirement.
• To Check and ensure the coated tablets should be kept in WIP area under lock & key as per SOP.
• To check and ensure the cleanliness of Capsule cubicle, equipment and environmental Condition (Eg:- tempreture,RH and pressure differential) within specified limit before Start and during Capsule filling process.
• To keep the area ready for line clearance.
• To do the physical verification of empty and filled Capsules as per MMD-I in presence of Production & verified by QA person.
• To do the proper and maximum utilization of machines.
• To Check and ensure about that the process should be as per BMR, if any deviation it should be informed to supervisor.
• To Complete Manufacturing and capsule filling Operation with in time & keep the empty and filled capsule in WIP area & maintain its record.
• To reduce breakdown time through proper handling and maintenance of the machine.
• To maintain the online documentation as per GMP guidelines.
• To clean and maintaining equipment change part and records as per requirements.
  

• To ensure that Zero accident & Zero tolerance in the area.
• To ensure use the correct PPE, s.
• To participate in various Awareness trainings on Environment, Health and Safety.
  

CFT Meeting

• Regularly attend the sop,s training as per the plan.
• Participate in resolving the issues in the CFT being a team member, and helping to resolve machine related issues.
  

Principal Accountability

• To maintain quality and productivity.
• To ensure that Zero accident & Zero tolerance in the area.
• To follow all respective SOPs, BMR procedure & Discipline in the department & Operation.