Đến nội dung chính
tuyển dụng.app
← Abbott

Fie QA Manager - Pharmaceuticals Division

Abbott · Hồ Chí Minh
Ứng tuyển tại trang chính thức ↗
Loại hình
Toàn thời gian
Hình thức
Tại văn phòng
Cấp bậc
Trưởng / Phó phòng
Ngành nghề
Dược phẩm
Mức lương
Thương lượng
Địa điểm
Hồ Chí Minh, Hồ Chí Minh, Hồ Chí Minh

Tổng quan

  • 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
  • Quality Operations at imported product warehouse
  • 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.
  • 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.
  • Quality System Management
  • 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 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.
  • 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.
  • 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.
  • 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.

Quyền lợi

  • 13-month salary & performance bonus
  • Premium Healthcare
  • Training & Development
Chế độ thưởngChăm sóc sức khỏeĐào tạo

Tóm tắt thông tin từ tin tuyển dụng chính thức. Xem bản gốc ↗

Quan tâm đến vị trí này?

Bạn sẽ được chuyển đến trang ứng tuyển chính thức của nhà tuyển dụng.

Ứng tuyển tại trang chính thức ↗
Đây là doanh nghiệp của bạn? Nhận quản lý trang, yêu cầu chỉnh sửa hoặc gỡ bỏ
→