Job Title: Quality Assurance Specialist
Location: Japan
Industry: Biotechnology
Company Overview: Join our leading biotechnology company dedicated to advancing healthcare through innovative and high-quality products. We are seeking a dedicated Quality Assurance Specialist to ensure our products meet the highest standards of quality and compliance.
Key Responsibilities:
- Develop, implement, and maintain quality assurance protocols and procedures in compliance with cGMP and regulatory requirements.
- Conduct regular audits and inspections of manufacturing processes to ensure adherence to quality standards.
- Review and approve production and quality control records.
- Manage and investigate quality-related issues, including deviations, non-conformances, and CAPAs (Corrective and Preventive Actions).
- Ensure proper documentation and archiving of quality assurance activities.
- Collaborate with cross-functional teams to support continuous improvement initiatives.
- Provide training and guidance to staff on quality assurance practices and regulatory requirements.
- Stay updated with the latest industry trends and regulatory changes to ensure compliance.
Qualifications:
- Bachelor's degree in Science, Chemistry, Pharmacy or a related field; advanced degrees are advantageous.
- Minimum of 5 years of experience in quality assurance.
- Strong knowledge of cGMP, regulatory requirements, and quality management systems.
- Excellent analytical, problem-solving, and communication skills.
- Proficiency in Japanese and English.
- Ability to work effectively in a fast-paced, dynamic environment.
