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Quality Assurance Manager
2 months ago
Job Summary:
Proclinical Staffing is seeking a dedicated Quality Assurance Manager to ensure the safety and compliance of pharmaceutical products. This role is pivotal in maintaining high standards of product quality and regulatory compliance.
Key Responsibilities:
- Participate in the maintenance of 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 to ensure accuracy and compliance.
- Conduct risk assessments and implement risk mitigation strategies to ensure product safety and quality.
- Manage the investigation and resolution of quality issues to ensure prompt and effective resolution.
- Provide training and development opportunities on QA processes to the company to ensure knowledge and skills are up-to-date.
- Collaborate with cross-functional teams to ensure product quality throughout the product lifecycle.
- 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.
- Strong knowledge of Good Manufacturing Practices (GMPs).
- Excellent communication and interpersonal skills.
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Agile thinker who can adapt to situations of high-speed change.
- Problem solver who can work through complex issues.
- Demonstrates a willingness to achieve goals together and respect the views of others.
