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Quality Assurance Manager
1 week ago
Job Overview
Biotech Healthcare is seeking a highly skilled Quality Assurance Manager to lead our quality management initiatives and ensure compliance with regulatory requirements. As a key member of our team, you will design, implement, and maintain a robust Quality Management System (QMS) framework that aligns with industry standards.
About the Role
- Develop and implement QMS processes, manage training initiatives, and drive projects related to quality and regulatory compliance.
- Lead internal audits and self-inspections to assess compliance with quality standards and identify areas for improvement.
- Investigate quality-related issues, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
Key Responsibilities
- Quality Management System (QMS) Development: Design, implement, and maintain a robust QMS framework in line with regulatory requirements and industry standards.
- Compliance & Documentation: Oversee the approval process for Site Master Files, Validation Master Plans, Quality Manuals, and stability summary reports.
- Audit & Risk Management: Lead internal audits and self-inspections to assess compliance with quality standards and identify areas for improvement.
- Project Leadership: Drive quality improvement projects and initiatives, collaborating with multidisciplinary teams to enhance operational efficiency and compliance.
Requirements
- Strong expertise in Quality Assurance, QMS implementation, and regulatory compliance.
- Proficiency in managing quality projects, conducting internal audits, and performing gap analyses.
- In-depth understanding of GMP, GDP, ISO 13485, and FDA regulations.
- Ability to lead and manage cross-functional teams effectively.
About Biotech Healthcare
We are an equal opportunity organization promoting diversity while ensuring no discrimination on any ground. We value innovation, teamwork, and continuous improvement. If you are passionate about quality and regulatory compliance, join us in shaping the future of medical devices.
