QA Manager (Pharmaceuticals)

Mô tả Công việc
Our client is a foreign-invested manufacturing company, now looking for QA Manager (Pharmaceuticals, 1900$, ID20038)
Pharmaceutical Quality System (PQS) Management
Documentation System Management: Develop, review, approve, and maintain quality documentation, including Standard Operating Procedures (SOPs), master batch records, and technical specifications.
Change Control: Evaluate and approve changes related to processes, equipment, materials, or personnel to ensure no adverse impact on product quality.
Deviation Management: Lead investigations of production deviations, perform Root Cause Analysis (RCA), and implement appropriate Corrective and Preventive Actions (CAPA).
Product Quality Review (PQR/APR): Conduct annual product quality reviews to monitor trends and ensure process consistency and stability.
Validation & Qualification
Develop and maintain the Validation Master Plan (VMP).
Oversee and approve validation and qualification activities, including equipment qualification (IQ, OQ, PQ), process validation, cleaning validation, and utility system validation (HVAC, RO/WFI water systems, compressed air).
Inspection & Compliance
Self-Inspection: Plan and conduct periodic internal audits to assess compliance with WHO-GMP requirements across all departments.
Supplier Qualification: Lead the evaluation and approval of suppliers for raw materials, packaging materials, and technical services.
Regulatory Inspections: Act as the primary contact for regulatory authorities (e.g., Drug Administration) during inspections, audits, and certification processes.
Production Oversight & Batch Release
Monitor in-process quality control (IPQC) activities to ensure adherence to SOPs during manufacturing.
Review batch production and quality control records prior to submission to the Qualified Person (QP) for batch release decision.
Training & Development
Develop and deliver training programs on WHO-GMP, occupational safety, and SOPs for all manufacturing personnel.