Senior QA Specialist GMP

RESPONSIBILITIES

• Overseeing and ensuring timely completion of quality system deliverables including nonconformance (NC) and corrective/preventive actions (CAPA) internal audit findings supplier audits and actions from management and data reviews.
• Performing other related duties as required.
• Managing and maintaining supplier documentation for production release and development activities.
• Reviewing manufacturing quality control (QC) and release records as well as documentation for medical devices and drug substances/products.
• Providing guidance on nonconformance situations and investigations evaluate root causes and corrective actions and ensure accurate and timely documentation closure.
• Updating standard operating procedures (SOPs) and instructions (INSs) and creating flow charts and other quality documentation.
• Publishing monthly reports on supplier qualifications quality metrics and key performance indicators (KPI) trends.

QUALIFICATIONS

• Minimum 3 5 years of experience in the pharmaceutical or medical device industry.
• Strong understanding of FDA Good Manufacturing Practices (GMP) regulations Medical Device Directive ICH Q7 ISO 13485 and sterilization standards.
• Excellent communication skills including verbal written interpersonal and listening abilities.
• Strong organizational skills.