Manager

Review and Approval of master documents like SOPs, specification, STPs, OPML, batch manufacturing, batch packing records and stability protocol. Review and Approval of quality system documents like change control, market complaints, deviation, OOS, OOT, CAPA etc. in QAMS. Review and participation in investigation of deviations, market complaints, OOS/OOT, incidents etc. Handling of recall and return goods, Field Alert Report, CAPA and participate in self inspection. Review of validation protocols, annual product quality review of drug product Perform the Quality risk assessment Preparation and review of hold time study protocols and reports. Review and maintain site quality management details Release or rejection of finished products in SAP for market distribution. Approval of various documents in SAP system To check the maintenance of the department, premises and equipment/instrument Work Experience 10-12 years Education Graduation in Pharmacy Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility