Quality Assurance & Compliance
· Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
· Ensure compliance with applicable regulatory requirements, company standards, and customer specifications.
· Assist in preparing for and coordinating internal, customer, and regulatory audits.
· Develop, review, and maintain quality policies, procedures, work instructions, and quality documentation.
Quality Control Operations
· Oversee inspection and testing activities for raw materials, packaging materials, in-process products, and finished goods.
· Review and approve quality records, inspection reports, and test results.
· Monitor product quality trends and identify opportunities for improvement.
· Ensure proper calibration and maintenance of laboratory and inspection equipment.
Investigation & Continuous Improvement
· Lead investigations related to product non-conformities, deviations, customer complaints, and quality incidents.
· Conduct root cause analysis using quality improvement tools and methodologies.
· Drive Corrective and Preventive Action (CAPA) processes and verify effectiveness of implemented actions.
· Participate in continuous improvement initiatives to enhance product quality, operational efficiency, and customer satisfaction.
Supplier & Customer Quality Management
· Support supplier qualification, evaluation, and ongoing quality performance monitoring.
· Collaborate with suppliers to address quality issues and implement improvement plans.
· Respond to customer quality concerns and support resolution activities.
Leadership & Collaboration
· Provide guidance and technical support to QA/QC staff and cross-functional teams.
· Support employee training programs related to quality systems, GMP practices, and quality standards.
· Promote a culture of quality, compliance, and continuous improvement throughout the organization.