
QA Specialist
5 days ago
Key Role Summary
Job OverviewIn this critical role, you will play a pivotal part in ensuring the quality and compliance of our supplier network. You will be responsible for leading the development and implementation of a robust supplier qualification program, leveraging your expertise in GxP-relevant suppliers to drive excellence across the organization.
As a seasoned QA professional, you will conduct thorough audits, assess supplier quality systems, and provide strategic input into procurement decisions to ensure seamless integration with our business goals. Your exceptional leadership skills will enable you to effectively collaborate with cross-functional teams, drive continuous improvement initiatives, and foster a culture of quality throughout the organization.
Key Responsibilities- Develop and implement a comprehensive supplier qualification program that meets or exceeds regulatory requirements
- Conduct regular supplier audits, assess their quality systems, and identify opportunities for improvement
- Collaborate with internal stakeholders to develop and execute strategies that promote quality and compliance
- Provide expert guidance on GxP regulations, industry best practices, and emerging trends to ensure our supplier network remains current and compliant
- Lead the review and approval process for supplier documentation, ensuring alignment with organizational policies and procedures
- Bachelor's degree or higher in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline
- Minimum of 7–10 years of QA experience in the pharmaceutical, biologics, or veterinary vaccine industry
- At least 5 years of hands-on experience in GxP supplier qualification and auditing, with demonstrated expertise in GMP and at least one of the following: GLP, GCP, GDP
- Strong understanding of quality management principles, risk-based approaches, and technical agreements
- Excellent communication and interpersonal skills, with the ability to build effective relationships with diverse stakeholders
- Solid knowledge of EU GMP, FDA regulations, OECD GLP, VICH GCP, and ICH guidelines
- Proven ability to plan, conduct, and report external audits independently
- Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues
- Proficiency in MS Office and QMS tools, with experience in eQMS platforms preferred
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