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Job description:
- Plant validation activities, including planning, organizing, leading, and controlling processes.
- Responsibilities include reviewing various documents such as the Site Master File, Quality Manual, and Validation Master Plans.
- Monitoring Qualification and Validation protocols and ensuring Quality Assurance for plant qualifications is essential.
- Participating in assessments related to drug manufacturing equipment and conducting impact and risk assessments are key duties. Investigating deviations, laboratory incidents, and non-conformances in coordination with other departments is necessary.
- Reviewing batch documents, approving Certificates of Analysis, and providing staff training are crucial tasks.
- Ensuring compliance with GMP through inspections and audits is a significant responsibility.
- Coordinating dossier preparation for regulatory agencies and handling inspections is part of the role.
- Other duties include evaluating stability data, conducting vendor audits, and ensuring environmental protection measures.
Job requirements:
- Minimum of 5 years' experience as a QA Manager in pharmaceuticals,
- Pharmacist license
- Proficiency in English.
QA director
Location | Tỉnh Bình Dương |
Industry | Healthcare/Life Sciences | Job reference | 15590 |
Job type | Permanent |
Salary | 40.000.000-60.000.000 |
Consultant email | phuong.do@manpower.com.vn |
Date posted | Feb 28, 2024 |
- Plant validation activities, including planning, organizing, leading, and controlling processes.
- Responsibilities include reviewing various documents such as the Site Master File, Quality Manual, and Validation Master Plans.
- Monitoring Qualification and Validation protocols and ensuring Quality Assurance for plant qualifications is essential.
- Participating in assessments related to drug manufacturing equipment and conducting impact and risk assessments are key duties. Investigating deviations, laboratory incidents, and non-conformances in coordination with other departments is necessary.
- Reviewing batch documents, approving Certificates of Analysis, and providing staff training are crucial tasks.
- Ensuring compliance with GMP through inspections and audits is a significant responsibility.
- Coordinating dossier preparation for regulatory agencies and handling inspections is part of the role.
- Other duties include evaluating stability data, conducting vendor audits, and ensuring environmental protection measures.
Job requirements:
- Minimum of 5 years' experience as a QA Manager in pharmaceuticals,
- Pharmacist license
- Proficiency in English.