Overseeing and ensuring timely completion of quality system deliverables, including non-conformance (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 non-conformance 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.
Seniority level
Associate
Employment type
Contract
Job function
Quality Assurance
Industries
IT Services and IT Consulting
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