AM - Quality Assurance

Job Description

Key Responsibilities. Shall be responsible for quality oversight in Production blocks and shall review process, procedure, facility and training. Batch release (or reject) activity for API s manufactured at all Plants. This includes review of BPRs, review of IOCBN, verification and distribution of PAF, review of product label and approved label, retaining control sample and verification, inspection as per the checklist for finished product release to customers and updating of finished product distribution records. Review & evaluation of change controls, clean room allocation form, material re-allocation form, reprocess approval form and Packing clearance form and closure of the same before the product release. Responsible for visual inspection and line clearance for the product change over activities. Perform the cleaning validation samples as per approved protocol. Must have knowledge on handling all QMS related activities. Shall be responsible to identify the area of improvement and to review the followings: To review training records on the particular operations that the employee performs. Plant area & pharma room cleaning is performed as per established procedure. Equipment status board are updated with current status. Availability of current version of SOP for operation and calibration of equipment in the work Place & accessible to operating personnel. Batch production records are placed in work stations during the entire operations.