At the heart of our quality management system lies a key position, that of Quality Assurance Specialist Lead. This individual will play a pivotal role in maintaining and improving our QMS, ensuring it remains compliant with ISO 13485 and GMP standards.
Key Responsibilities:
* Maintain and improve the QMS to ensure seamless operations and adherence to regulatory requirements.
* Coordinate internal/external audits, guaranteeing thoroughness and accuracy in assessments.
* Monitor and report on CAPAs, deviations, non-conformances, and change controls, facilitating proactive issue resolution.
* Manage controlled documents (SOPs, policies, batch records) and technical documentation, ensuring organized access and version control.
* Support risk assessments (FMEA, RCA) and change management processes, providing valuable insights for informed decision-making.
* Ensure audit-ready documentation for inspections and management reviews, minimizing potential risks and delays.
* Act as SME for document control systems and provide training to staff, empowering them to efficiently manage documentation.
Requirements:
* Degree (Level 8 or equivalent) in Science, Engineering, or Quality Management, demonstrating academic prowess in relevant fields.
* 2+ years experience in quality/document control within pharma or medical devices, showcasing practical knowledge and expertise.
* Strong understanding of GMP and ISO 13485 standards, highlighting familiarity with regulatory frameworks.
* Proficiency in electronic document management systems and MS Office, evidencing adaptability and technical skills.
* Internal Auditor certification (ISO 13485) is highly desirable, signifying advanced expertise in auditing practices.