QA director
Manpower
- Binh Duong
- Permanent
- Full-time
- 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.