Executive QA

• Monitoring of product quality, in-process control and manufacturing environment.
• Ensure effective implementation of system and procedure as per cGMP, ISO 13485 in shop floor, warehouse and engineering along with documentation.
• Sampling of FG control samples, stability samples and other samples as per requirement along with related documentation.
• Responsible for alarm review and trending as and when required.
• Perform Calibration of IPQA Instrument/Equipment.
• Stage wise review of batch manufacturing, packaging documents & other quality documents.
• Handling of material on shop floor through approval for MRN, LRN, and MRQN.
• Submission of In-process analysis report from QC to production after review.
• Handling of non-conformance.
• Approval of line clearance during product changes over/Batch change over.
• To ensure the EHS (Environment, Health and Safety) related activities to be completed on time and to support EHS activities as per requirement. To report near miss and incidences as observed as per EHS requirement.
• To ensure data integrity compliances at site and while performing activities.
• Handling of Ensur, SAP & trackwise activity as per Quality Assurance procedure.

Online stage wise BMR/BPR review.

B. Pharma