Fie QA Manager - Pharmaceuticals Division

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QA Manager of the local imported warehouse and assures that quality related matters associated with imported products commercially distributed in Vietnam market conform to current Good Manufacturing Practices (cGMP), Good Storage Practices (GSP), Abbott Quality standards, and other applicable regulatory standards.
Position Accountability / Scope:
This individual contributor role is responsible for overseeing and performing all quality control activities associated with imported products and distribution operations to ensure product quality, safety, and regulatory compliance
Maintain quality documents to comply with Abbott Policies & Procedures and local regulations.
Full authority in controlling the overall quality operations of the warehouse. This includes budgeting and facilities.
Review and approve operating procedures to comply with Abbott policies and local regulations within the scope of the position.
Within the guidelines of QA management and GSP Compliance, has authority to recommend, evaluate and implement changes in the existing QA operation
MAIN RESPONSIBILITIES
1. Quality Operations at imported product warehouse
1.1 Warehouse quality compliance
Manage daily quality operations for the FIE warehouse in compliance with applicable GSP/ GDP requirements, local regulations, and company quality standards.
Coordinate and supervise over-labeling and redressing activities to ensure compliance with approved procedures and quality requirements.
Review and maintain warehouse SOPs, batch records, and quality documentation to ensure accuracy, completeness, and data integrity.
Maintain quality records and documentation in accordance with document control requirements.
1.2 Product Release, Rejection and Investigation
Review batch documentation and related quality records to support product release and rejection decisions.
Perform quality assessment of warehouse-related events and product quality issues.
Coordinate product investigations, including product impact assessment, root cause analysis, and follow-up actions.
Escalate critical quality issues and disposition recommendations to the CDQA Manager when required.
Maintain product hold, release, and rejection records in accordance with approved procedures.
2. Quality System Management
2.1 Change Control
Initiate, assess, coordinate, and maintain Change Controls related to warehouse operations, facilities, equipment, suppliers, and processes.
Track implementation of approved changes and verify completion of required actions.
Support impact assessment and effectiveness verification activities.
2.2 Deviation Management
Manage deviations and nonconformances associated with warehouse and distribution activities.
Lead investigations, root cause analysis, risk assessment, and CAPA development.
Monitor CAPA implementation and verify timely closure of assigned quality records.
3. Customer Complaint Management
Receive, assess, and manage product quality complaints in accordance with company requirements.
Coordinate complaint investigations with manufacturing sites, distributors, and relevant stakeholders.
Review returned product evaluations and maintain complaint documentation.
Perform complaint trending and identify recurring quality issues for escalation.
Ensure complaint records are completed and closed within established timelines.
4. Internal Audit and Gemba
Plan, conduct, and document internal audits and self-inspections for the FIE warehouse.
Conduct routine warehouse inspections and Gemba activities to verify compliance with GSP requirements.
Identify compliance gaps, initiate corrective actions, and monitor actions through completion.
Support continuous improvement initiatives arising from audit and Gemba findings.
5. Regulatory Audit and GSP Re-certification
Prepare and maintain inspection readiness for the FIE warehouse in accordance with GSP requirements and company quality standards.
Participate in regulatory inspections and GSP re-certification audits, providing documentation, records, and quality system support as required.
Coordinate responses to inspection observations and findings with relevant functions.
Develop, track, and verify the implementation and effectiveness of corrective and preventive actions (CAPAs) arising from inspections and audits.
Maintain inspection documentation and support timely communication with local health authorities and internal stakeholders.
Prepare inspection documentation, facilitate auditor requests, and coordinate responses to inspection observations.
Track commitments and CAPAs resulting from inspections through completion.
6. Others
Manage other affiliate operations which are cross trained.
Effectively communicate with all level of staff and have a good working relationship with management and employees to promote teamwork.
Perform other activities or special projects as assigned by management and/or instructed by CDQA manager.