QA Specialist - Pharma (Contract 9 months)

Mô tả Công việc
Product management:
Approve SKU, BoM and Process Order.
Issue, check and arrange batch record, analytical sheet.
Review batch manufacturing record and FP analysis record prior to the batch release decision of responsible or delegated person.
Release the batch on system and extract FG CoA.
Manage deviation and ILI: investigate and follow deviation and ILI related RMs and assigned product.
Track progress implementing corrective and preventive actions related to quality to ensure appropriate and timely improvements.
Manage assigned change controls: ensure approval before application, perform and follow up blocking works, ensure completion before next step, and monitor closure as monthly planning.
Manage customer complaints in QA liquid production team: assign and monitor investigation deadlines; investigate and respond to assigned product complaints.
Act as Administrator for assigned equipment and systems; perform assigned periodic audit trail.
Perform annual product quality review (PQR) for assigned products and follow up CAPA performance.
Support establishing Validation Master Plan and monitor implementation of assigned work schedule.
Perform qualification (performance qualification, process qualification, cleaning process, transportation validation, and support equipment qualification): prepare protocol, monitor, assess, report results, and follow up proposals.
• Quality system management:
Prepare and update SOPs related to the assigned field; check compatibility between practice and GMP, GLP, GSP, Halal, and local/global requirements.
Participate in regulatory audits/inspections.
Perform supplier audits and monitor supplier CAPA performance.
Participate in preparing quality agreements for assigned suppliers.
Manage RM and PM complaints.
Prepare periodic reports (monthly, quarterly); collect, process, and report quality-related data upon request.
• Project:
Coordinate with departments and suppliers to plan, execute, monitor, and report on projects related to simplification, energy saving, cost reduction (C2W, I2W activities, backup RMs/PMs), and environmental protection.
• APU activities:
Participate in assigned APU meetings.
Coordinate with relevant departments for APU activities.
• Others in Quality Assurance Department:
Proactively simplify all quality-related activities.
Report non-compliance with standards, GxP requirements, and regulations to appropriate management.
Support other departmental activities when necessary.
• Compliance with HSE rules and policies.