QA Manager
Job Title: Quality Manager - Pharmaceutical Industry
Location: Japan
Company Overview: Join our innovative and forward-thinking pharmaceutical company, committed to improving health and well-being worldwide. We are dedicated to producing high-quality, safe, and effective pharmaceutical products, and are seeking a talented Quality Manager to uphold our standards and drive continuous improvement in quality management.
Job Description: The Quality Manager will be responsible for overseeing the quality assurance and control processes, ensuring compliance with regulatory requirements, and maintaining the highest standards of product quality. This role will require strong leadership, analytical skills, and a deep understanding of pharmaceutical industry regulations.
Key Responsibilities:
Develop, implement, and maintain quality management systems in compliance with local and international regulations (GMP, FDA, EMA, PMDA).
Lead and manage the quality assurance team, providing guidance, training, and support.
Conduct regular audits and inspections to ensure adherence to quality standards and regulatory requirements.
Investigate and resolve quality issues, implementing corrective and preventive actions as necessary.
Collaborate with cross-functional teams (R&D, production, supply chain) to ensure quality is integrated into all stages of product development and manufacturing.
Monitor and analyze quality performance metrics, identifying areas for improvement and driving continuous improvement initiatives.
Maintain documentation and records related to quality management, ensuring accuracy and completeness.
Stay updated on industry trends, regulatory changes, and best practices in quality management.
Qualifications:
Bachelor's degree in pharmaceutical science, chemistry, biology, or a related field. A Master's degree is preferred.
Minimum of 5 years of experience in quality assurance or quality control within the pharmaceutical industry.
In-depth knowledge of GMP, FDA, EMA, and PMDA regulations.
Strong leadership and team management skills.
Excellent analytical and problem-solving abilities.
Effective communication and interpersonal skills.
Proficiency in Japanese and English, both written and spoken.
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