Junior Officer, IPQA

Job Description

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 and coordination during validation studies (process / cleaning validation). Responsible for routine monitoring of Manufacturing Areas. 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 areas Responsible for preparation and implementation of SOP's Good Documentation recording and updation 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. Responsibilities other than defined in the JD are to be done as per instruction of HOD Bachelor's Degree in Pharmacy, Microbiology, Biotechnology, Chemistry, or a related field. Master's Degree in Quality Assurance, Regulatory Affairs, or a related field (preferred but not mandatory). 3-5 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry. Hands-on experience with GMP inspections , environmental monitoring , and aseptic process simulations . Proven track record in sampling . Experience in reviewing Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) . Familiarity with SOP preparation and implementation . Involvement in change control , deviation management , and failure investigations .