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      Công ty TNHH Bình Việt Đức (BIVID)

      Validation Manager

      Công ty TNHH Bình Việt Đức (BIVID)
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      Location

      Ho Chi Minh

      • Salary

        Competitive

      • Experience

        6 - 8 Years

      • Job level

        Manager

      • Deadline to apply

        22/07/2025

      Benefits

      • Laptop
      • Insurance
      • Allowances
      • Incentive bonus
      • Healthcare
      • Training Scheme
      • Salary review
      • Seniority Allowance
      • Annual Leave

      Job Description

      • 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.

      Job Requirement

      • 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.

      Work location

      Ho Chi Minh
      62/36 Trương Công Định, Phường 14, Tân Bình, Hồ Chí Minh

      More Information

      • Degree: Bachelor
      • Probationary period: 2 months
      • Age: 35 - 55
      • Working time:Monday - Friday ( 8am - 5pm); Saturday (8am - 12am)
      • Colleagues: Respectful and Understanding
      • Benefit:

        • 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

      • Holidays: Anual leave: 12 days/year
      • Salary: Competitive

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