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| Job Location | Ahmedabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Manufacturing |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Major Roles & Responsibilities:To ensure the cleanliness of area and machines before starting the filling process.To ensure SIP of machine before commencing the filling activity.To ensure availability of released bulk solution, all tools required before commencing the filling activity.To ensure availability of Batch manufacturing record before commencing the filling activity.To ensure the compliance of environmental conditions before commencing the filling activity.To ensure the line clearance from IPQA before commencing the filling activity.To record all the activities in the approved formats at the time of observation/activity is performed.To have thorough knowledge of SOP of own working area and ensure to practice it.To follow clean room behaviors strictly.Ensure that the PM, calibration and validation of equipment/system/facility is completed as per approved schedule.Ensure the housekeeping of the area is in controlled state.Ensure all safety norms are followed in respective area.Keep self and team updated about CGMP requirement.Ensure completion of all required training for self as well as team.Skills Required- Functional/BehaviouralKnowledge about the working /design principles equipment, system, facility utilized for injectable manufacturing.Knowledge about documentation requirements as per current regulatory norms and best industry practices.Exposure to international regulatory audits.Good verbal and written communication skills.Self-motivated and result oriented.Leadership quality.,
Keyskills :
calibrationregulatory auditsBatch manufacturing