By working cooperatively with VP, CSO, COO and other department heads, the primary responsibility of the QA Manager is to lead the QA team to establish the quality management system, operate and maintain a state of control with all aspects of cGMP in the compliance with Health Canada and FDA regulations as well as customer requirements.
Responsibilities and/or Duties
1. Quality System
To establish, operate and maintain the company Quality system
2. Batch Record Review
To review the batch record review (including raw material spec, testing result review, QC release, finished product spec, testing result review, QC release, SOI review, packaging SOI review, list deviation, OOS, etc.)
To Perform the Internal cGMP audit
To Issue the Audit Report
Annual Product Review (product quality to related documents, procedures, materials, customer complaint, etc)
FDA, Health Canada Inspection and response
Customer audit and response
Customer complaint handle and response
CAPA (Corrective action, preventative action)
OOS (out of specifications)
SOP maintaining, updating, training and monitoring that all departments are using most current SOP
Validation design and execution (including process validation, cleaning validation, validation master plans, validation protocols, validation report, Equipment IQ/OQ/PQ, etc)
Product risk assessment
Monitoring necessary calibration performance
All log book trace and make sure all department keep good records
Label control (in control, process control, out control, stock control, etc.)
Act as an authority on release, rejection, complaint management and potential recall of all products sold by the company.
Act as a primary decision maker on release or rejection of materials based upon sound judgment and compliance to regulatory requirements, reports and specifications.
Act as an authority for all interaction with Health Canada, outside agencies and contacts for quality assurance and regulatory compliance related activities and documentation.
Act as an authority on validation of IQ/OQ/PQ, which include, but are not limited to, test methods, machines, operation process, cleaning.
Audit, correct and approve all manufacturing, packaging and kitting batch records including associated documentation, investigations and certificates of analysis to assure compliance with cGMP.
Write, review and revise SOPs, quality policies and procedures and customer methods to ensure continuous compliance with cGMP, regulatory and customer requirements.
Review commercial contracts and technical/quality agreements with a strategy towards compliance with cGMP
Maintain and review each batch record and all shipment authorizations.
Manage the remediation of all batch related and out of specification (OOS) and (DIR) investigations and actions, perform investigations as needed.
Maintain filing and tracking for all complaints and generate the annual complaint report for each product for submission to regulatory agencies.
Update other departments regularly to provide information updates on product release and complaint issues.
Provide technical assistance and training in areas of expertise for the company.
Act as the primary team member in follow up for documentary deficiencies, including managing internal manufacturing personnel and contractors.
Review and approve method transfer and validation protocols and reports;
Co-ordinate and actively participate in the effective management of the general and GMP training programs, which includes scheduling, conducting and evaluation of training for staff on SOP (company and customer) and GMP requirements.
Provide assistance and technical support for equipment (or process) optimization, validation, calibration, qualification or certification.