GMP Compliance Specialist
1 week ago
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:
- Develop and maintain the Quality Management System (QMS) in compliance with regulatory standards.
- Conduct internal and external audits, and participate in regulatory inspections to ensure compliance.
- Ensure all products meet regulatory requirements and industry standards.
- Prepare for and participate in regulatory inspections and audits to maintain compliance.
- Oversee the preparation, review, and approval of quality-related documentation.
- Conduct risk assessments and implement risk mitigation strategies to ensure product quality.
- Manage the investigation and resolution of quality issues to minimize downtime.
- Provide training and development opportunities on QA processes to the company.
- 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.
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