Key Responsibilities
-Lead the implementation, maintenance and continuous improvement of ISO 9001, cGMP and Quality Management Systems.
-Represent the plant during customer, ISO, supplier and regulatory audits.
-Manage internal audits, self-audits, non-conformances and timely closure of audit observations.
-Review and approve Certificates of Analysis, batch records and batch-release activities.
-Oversee quality testing of raw materials, packing materials and finished products.
-Review DQ, IQ, OQ and PQ, along with calibration and validation activities for processes, machines, equipment and instruments.
-Lead investigations related to customer complaints, deviations and non-conforming materials.
-Ensure effective implementation of root-cause analysis, CAPA and change-control systems.
-Organize Management Review Meetings and follow up on agreed action points.
-Maintain and update QMS manuals, SOPs, specifications and quality documentation.
-Work closely with Production, Maintenance, Technical, Logistics, HR and other departments to achieve plant-quality objectives.
-Drive improvements in quality KPIs, product reliability, compliance and customer satisfaction.
-Lead and develop the plant Quality team.
.png)
