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Quality Assurance Director
2 months ago
Job Summary:
Proclinical Staffing is seeking a highly skilled and experienced Senior Quality Assurance Manager to join our team. As a key member of our organization, you will play a pivotal role in ensuring the safety and quality of our pharmaceutical products, as well as ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:
- Maintain and improve the Quality Management System (QMS) to ensure compliance with regulatory standards.
- Conduct internal and external audits, and participate in regulatory inspections to ensure product quality and compliance.
- Oversee the preparation, review, and approval of quality-related documentation, including risk assessments and mitigation strategies.
- Manage the investigation and resolution of quality issues, and provide training and development opportunities on QA processes to the company.
- Collaborate with cross-functional teams to ensure product quality throughout the product lifecycle, and identify opportunities for process improvements and lead initiatives to enhance quality and efficiency.
Requirements:
- Bachelor's degree in Pharmaceutical Science, Biologics, Biotechnology, Biochemistry, or a related field. A Master's degree is preferred.
- Experience in quality assurance within the pharmaceutical industry, with a strong knowledge of Good Manufacturing Practices.
- Excellent communication and interpersonal skills, with the ability to manage multiple projects and priorities in a fast-paced environment.
- Agile thinker who can adapt to situations of high-speed change, and a problem solver who can work through complex issues.
- Demonstrates a willingness to achieve goals together and respect the views of others.
