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Quality Assurance Specialist
1 month ago
As a key member of our Quality Assurance team, you will play a critical role in ensuring the highest standards of quality and compliance in our manufacturing processes.
Key Responsibilities:
- Assist in setting up and maintaining continuous process validation (CPV) for commercial products, reviewing batch records and extracting critical process data.
- Provide quality operations support for internal, vendors, and licensing partners, including deviation review, change control action finalization, and CAPA identification.
- Populate manufacturing and quality control related spreadsheets with current data and maintain accurate records.
- Work closely with the Quality Assurance team to set up regulatory inspection dossiers and prepare PowerPoint documents contextualizing control systems.
- Develop and maintain training materials in Veeva Vault Training electronic system and assist in setting up metrics for the Company's continuous improvement plan.
Requirements:
- Bachelor's degree in Engineering, Chemistry, or a Life Sciences related field from an accredited university.
- Demonstrated attention to detail and excellent interpersonal skills, with the ability to interact with scientific and non-scientific personnel.
- Ability to work in a dynamic, fast-paced environment with shifting priorities and adapt to changing needs.
- Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook) and Adobe Pro.
About Asahi Kasei:
Asahi Kasei is a global company committed to creating value for society through innovative technologies and solutions. We believe in the importance of diversity and inclusion in the workplace and strive to create a culture that values and respects individual differences.