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Quality Assurance Manager
2 months ago
Proclinical Staffing is seeking a dedicated and experienced 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 Quality Management System (QMS): Collaborate with internal departments and external contractors to ensure the QMS is compliant with regulatory standards.
- Conduct Audits and Inspections: Participate in internal and external audits, as well as regulatory inspections, to ensure product quality and compliance.
- Ensure Regulatory Compliance: Verify that all products meet relevant regulations and guidelines.
- Prepare for Regulatory Inspections: Collaborate with cross-functional teams to prepare for and participate in regulatory inspections and audits.
- Oversee Quality Documentation: Manage the preparation, review, and approval of quality-related documentation.
- Conduct Risk Assessments: Identify and mitigate risks to ensure product quality and compliance.
- Investigate and Resolve Quality Issues: Manage the investigation and resolution of quality issues.
- Provide Training and Development: Offer training and development opportunities on QA processes to the company.
- Collaborate with Cross-Functional Teams: Work with cross-functional teams to ensure product quality throughout the product lifecycle.
- Identify Process Improvements: Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency.
- Education: Bachelor's degree in Pharmaceutical Science, Biologics, Biotechnology, Biochemistry, or a related field. A Master's degree is preferred.
- Experience: Experience in quality assurance within the pharmaceutical industry.
- Knowledge: Strong knowledge of Good Manufacturing Practices.
- Skills: 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, and a willingness to achieve goals together and respect the view of others.
