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Lead and manage the GMP validation team to ensure compliance with Good Manufacturing Practices (GMP) across all international standards, including EU-GMP, FDA-GMP, and WHO-GMP, for plasma-derived products and injectable drugs.
Develop, implement, and maintain compliance strategies for GMP validation in line with EU, FDA, and WHO regulatory requirements.
Oversee and ensure the validation process for manufacturing equipment, systems, and processes in the plant meets the highest international GMP standards.
Prepare and manage validation protocols, reports, and risk assessments for EU-GMP, FDA-GMP, and WHO-GMP compliance, ensuring that all manufacturing processes meet regulatory expectations.
Lead the coordination with QA, regulatory affairs, and production teams to implement best practices for GMP compliance and to address any corrective actions required.
Conduct and lead GMP audits (both internal and external) to ensure the facility’s compliance with EU-GMP, FDA-GMP, and WHO-GMP standards, preparing the company for regulatory inspections
Ensure all GMP documentation is maintained and prepared for audits and inspections by local and international regulatory bodies.
Provide training, leadership, and mentorship to the validation team, fostering a culture of excellence and continuous improvement in GMP practices.
Continuously monitor and report on GMP compliance performance within the organization and identify potential non-conformities, implementing corrective actions where necessary.
Stay informed of the latest changes in international GMP regulations and trends in the pharmaceutical industry, ensuring the organization remains compliant with evolving standards.
Yêu Cầu Công Việc
Age: 35–55, Vietnamese or foreign candidate.
Bachelor’s or higher degree in Pharmacy, Life Sciences, Engineering, or related field.
At least 6 - 8 years of experience in GMP validation in the pharmaceutical or biopharma manufacturing industry, with extensive exposure to EU-GMP, FDA-GMP, and WHO-GMP regulations.
Strong understanding of GMP standards, including EU-GMP, FDA-GMP, and WHO-GMP, and regulatory compliance systems in pharmaceutical manufacturing.
Proven track record of leading GMP audits and managing GMP compliance across multiple international standards.
Expertise in GMP validation processes for manufacturing equipment, systems, and production processes.
Strong leadership, organizational, and communication skills, with experience managing teams and cross-departmental projects.
Excellent problem-solving and risk assessment abilities to handle GMP compliance challenges.
Fluent in English (written and spoken); proficiency in Vietnamese is essential.
Experience with GMP audit preparation, automation systems, and validation tools is highly desirable.
Thời gian làm việc: Monday - Friday ( 8am - 5pm); Saturday (8am - 12am)
Đồng nghiệp: Respectful and Understanding
Phúc lợi:
• Competitive salary and performance-based incentives.
• Full legal benefits
• Opportunities for career development and leadership growth in a leading biopharma company.
• Relocation support for international candidates.
• Work with state-of-the-art facilities and an international team of industry
Thông Báo Việc Làm
