Key Responsibilities
-Implement, maintain and improve ISO 9001:2015, ISO 15378:2015, cGMP and Quality Management Systems.
-Support implementation of the organization’s management system and coordinate quality-improvement initiatives.
-Review testing and quality status of raw materials and packing materials.
-Ensure controlled issuance and maintenance of quality formats and documentation.
-Review maintenance and calibration status of quality equipment and instruments.
-Review DQ, IQ, OQ and PQ activities related to processes, machines, equipment and instruments.
-Coordinate validation, calibration and quality-system documentation activities.
-Organize Management Review Meetings and track closure of agreed action points.
-Review incoming material quality checks and ensure timely reporting to concerned departments.
-Prepare batch records and support batch-release activities in consultation with Production, QC and Plant leadership.
-Take responsibility for batch release in the absence of the Quality Head.
-Conduct and support internal quality audits and cross-functional audits.
-Monitor audit non-conformances and ensure timely closure.
-Investigate customer complaints and coordinate root-cause analysis, CAPA and change control.
-Ensure proper handling of non-conforming raw materials and finished goods.
-Maintain GMP, safety, cleanliness and hygiene standards across the plant.
-Review QMS and management-system documentation and records regularly.
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