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.

Yêu Cầu Công Việc

• University graduated, preferably in pharmaceutical or chemistry.

• At least 2-year experience working in a pharmaceutical company, product handling.

• Basic knowledge in GMP, HSE.

• Fluent in English (4 skills).