Responsibilities & Duties:

• Identify quality principles related to products and processes (monitoring, measuring, continuous improvement).
• Define & apply continuous improvement techniques- Lean mfg., 8D, PDCA, etc. to solve quality problems.
• Apply structured meeting management techniques - creating & following an agenda, minutes, ground rules.
• Document Control - Create and update GMS documents including SOP and Work Instructions.

Statistical techniques

• Define & determine the applicable statistical technique in various situations (calculations, charts)

Regulatory

• Drug Master File and Letters of Authorization Management with 3rd party and customers
• Manage regulatory requests from customers.
• Customer and ISO Audit management - Scheduling, CAPA, follow-up, and Reports
• Assist with Quality Agreements, Questionnaires, and subtler supplier change control.
• Manage MICRO testing, pest control, cleaning validations, recall, and purchasing for Quality Dept.

General Quality Team Support

• Perform tests (following a protocol) and make the report with conclusion.
• Prepare Inspection plans and instructions.
• Certificate of Analysis & Certificate of Compliance management.
• SAP master data for quality - update and assist management.

CAPA - Corrective and Preventive Action

• Identify and apply corrective and preventive methods for products and processes.
• Assist QNS coordinator to open, investigate and close customer and supplier complaints.

Additional Responsibilities:

• Customer correspondence - verbal and document
• Assist with Internal & External Audits
• Liaison with other departments and customers