Key Roles and responsibilities:
§ 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.
§ Review all BMR, BPR for their correctness and retention until destruction.
§ Review of quality records in periodical basis and review of analytical data in COA.
§ Issuance of BMR, BPR, Cleaning checklists, Logbook and Labels as per requirement.
§ 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.
§ Training of new employees, system practices and procedure to develop competency.
§ Review and approval of executed batch manufacturing, packaging documents & other quality documents.
§ Handling of material on shop floor through approval for MRN, LRN, and MRQN.
§ Handling of non-conformance.
§ Approval of line clearance during product changes over.
§ Preparation and Sharing the COC, finished product certificate of analysis report , batch records,API Identification certificate, USDA certificate to the ware house and customer .
§ 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.