Job Detail
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Offerd Salary (USD) Thoả thuận
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Career Level Giám đốc
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Experience 5-7 Years
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Gender Male
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Sector TP.HCM, Bình Dương , Đồng Nai
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Industry Dược/Công nghệ sinh học, Sản Xuất , QA/QC
Job Description
Our client is a foreign-invested manufacturing company, now looking for QA Manager (Pharmaceuticals, 1900$, ID20038)
Pharmaceutical Quality System (PQS) Management
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.
- 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).
- 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.
- 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.
- Develop and deliver training programs on WHO-GMP, occupational safety, and SOPs for all manufacturing personnel.
Requirement
- Gender: Male
- Age: 30 – 50 years old
- Bachelor’s degree or higher in Pharmacy (Licensed Pharmacist) with a valid Practicing Certificate.
- Minimum of 5 years of experience in a similar position within a pharmaceutical manufacturing environment.
- This role is required to be officially registered as the person responsible for Quality Assurance under the factory’s GMP license.
- In-depth knowledge of WHO-GMP, GLP, GSP principles, and current pharmaceutical regulations.
- Proficient in English (both written and spoken).
