
Senior Quality Assurance Associate
2 weeks ago
Key Role Summary:
Job DescriptionWe are seeking a seasoned professional to join our team as an Associate Quality Assurance Specialist. The successful candidate will be responsible for ensuring compliance with quality agreements, supporting key partner and supplier assessments, and overseeing quality tasks in alignment with GMP/GDP standards.
This role requires a strong understanding of GMP/GDP requirements and their application in pharmaceutical quality. The ideal candidate will have experience in overseeing the quality of suppliers or external parties, strong technical writing skills, and the ability to work independently with minimal supervision.
The Associate Quality Assurance Specialist will play a crucial role in ensuring quality standards are met through collaboration with internal teams, external partners, and suppliers, while driving continuous improvement initiatives and operational excellence across the supply chain and alliance processes.
The selected candidate will possess a Master's degree and 1-3 years of experience in related fields, or a Bachelor's degree and 3-5 years of experience in related fields, or a Diploma and 7-9 years of experience in related fields. They will also have a strong continuous improvement attitude and experience with lean practices.
The Associate Quality Assurance Specialist will be responsible for:
- Ensuring adherence to quality agreements with external partners, identifying performance improvement opportunities, and managing supplier relationships.
- Performing partner assessments related to Change Control and Deviation records, ensuring alignment with quality standards.
- Supporting various QA tasks in support of Partnership Alliance Quality, including document revisions, redactions, and supporting partner audits in accordance with quality agreements.
To succeed in this role, the ideal candidate will possess the following skills and qualifications:
- Strong understanding of GMP/GDP requirements and their application in pharmaceutical quality.
- Experience in overseeing the quality of suppliers or external parties.
- Strong technical writing skills with experience in documentation and regulatory compliance.
- Experience in Alliance Management, including managing external partnerships and ensuring quality across the supply chain.
We offer a competitive benefits package to support your health and well-being, opportunities for professional growth and career development in a leading biopharmaceutical company, and a collaborative environment that values continuous learning and innovation.
OthersWe value autonomous individuals who can work under pressure while maintaining teamwork. If you are a detail-oriented, energetic, and highly motivated professional with a 'can-do' attitude, we encourage you to apply for this exciting opportunity.
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