Assistant Manager

pay 5 0000 00 - 100 000 00 per month Job description Key Responsibilities Assist in managing QA activities across production packaging and documentation Support internal audits regulatory inspections and CAPA implementation Review and approve batch records change controls and SOPs Coordinate with cross-functional teams to ensure compliance with quality standards Train and guide QA staff on quality practices and GMP requirements To monitor compliance of GMP and GLP requirements To active participate and compliance of the client regulatory audit and self-inspection To handle and maintain the QMS Documents such as Change control Incident Deviation CAPA OOS Recall Cleaning validation and Market complaints Maintain annual trends of it To give training to new employees preparation of Job responsibility and also give schedule training To prepare and revise the SOPs and relevant formats as and when require To prepare update and execute Site master file Validation master plan Quality manual To monitoring of Stability chamber and BOD Chambers To release batch and approve any document in the absence of Head QA Asst Manager To review APQR Annual product quality review To review PV Hold time BMR BPR Specification MOA Stability protocol Stability schedule To review technology transfer documents To check and approve artwork of carton outer carton foil leaflet Shipper etc To do require entries in ERP System such as add and verify master formula of RM PM addition of generic master RM PM Other material master upload artwork in ERP To monitor document control room To review batch numbers for products To monitor pest control activity To monitor review handle retrieval of BMR BPR and Batch Close To review and release Microbial limit test reports To review Batch creation Procurement planning in ERP To review inspection and destruction of control samples as per SOP To issue retrieve distribute master obsolete storage and handling of documents of all departments To prepare review qualification documents take part during qualification To check party sample and send to parties as and when required To verify 2D shipper label In process checks at granulation compression coating stage To check and give line clearance at each stage like dispensing granulation blending compression coating capsule filling etc Sampling and send to QC with entry in ERP system and sample testing intimation slip Sampling of in process sample process validation hold time stability sample control sample cleaning validation and Swab rinse samples To check and monitor on line documents like environmental monitoring records BMR BPR usage logs of equipment change part accessories and other logbooks To perform Acceptable Quality level AQL of each stage like compression coating inspection packing To Review of BMR stage wise and batch release for the next stage Status label checking for area system product container change part materials machines etc Handling and Monitoring of rejection at each stage Handling and Calibration of IPQC instruments Monitoring and checking of cleaning of manufacturing area drain janitor and wash rooms To check record cleaning environmental monitoring records of IPQA area To check and monitor primary packing line and to perform in process test In process check and line clearance for primary and secondary packing Job Types Full-time Permanent Benefits Cell phone reimbursement Commuter assistance Flexible schedule Health insurance Internet reimbursement Paid sick time Paid time off Provident Fund Job Type Full-time Pay 50 000 99 - 100 000 98 per month Benefits Cell phone reimbursement Commuter assistance Internet reimbursement Paid sick time Provident Fund Application Deadline 03 09 2025