Assistant Manager - IPQA - QA - Sterile Oncology
Amneal Pharmaceuticals
Date: 1 day ago
City: Hyderabad, Telangana
Contract type: Full time
Job Description
Qualification - B.Pharmacy, M.Pharmacy, M.Sc.
- Responsible for commercial batch release to market.
- Responsible for in process Quality Assurance activities.
- Responsible for In process Quality Assurance checks during Manufacturing, packing operations.
- Responsible for line clearance of manufacturing, Packing and dispensing activities.
- Responsible for assurance of cleaning, sterilization and aseptic manipulations of components.
- Responsible for Sampling of Cleaning Validation & Compilation of the records.
- Responsible for Sampling & compilation of Process Validation Reports (PVRs)
- Responsible for sampling and coordination during validation studies (process / cleaning validation).
- Responsible for routine monitoring of Manufacturing Areas.
- Good Documentation recording and updation.
- Responsible for Review of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs).
- Responsible for the routine GMP Inspection & review of Quality Records of other departments.
- Responsible for monitoring in Aseptic process simulation study.
- Responsible for Preparation and Compilation of Media Fill Protocol , Report.
- Involve in Initiation of Change Control ,Deviation and Participate in Failure Investigation.
- Responsible for environmental monitoring (Viable) in liquid, lyophilized and dry powder manufacturing
- Responsible for preparation and implementation of SOP's
- Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule.
- Responsible for personnel monitoring.
- Responsible to participate in qualification, requalification, area qualification activities.
- Activities other than in the Job responsibility are to be done as per requirement of HOD.
Qualification - B.Pharmacy, M.Pharmacy, M.Sc.
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