QA PL Drug Product 100 %

Key Responsibilities

• Supervise compliance and customer quality agreement activities for drug product operations
• Establish and negotiate quality agreements in collaboration with relevant teams
• Serve as the primary point of contact for quality assurance-related inquiries and complaints from customers
• Manage interactions regarding changes, deviations, technical complaints, and out-of-specification results
• Represent quality assurance in cross-functional teams and maintain effective interfaces with manufacturing, quality control, and engineering teams
• Act as the quality assurance representative in project teams and customer meetings during technical transfers
• Support and facilitate project-specific risk assessments and regulatory gap assessments
• Review and release product-specific documentation, including process descriptions, manufacturing protocols, and test plans
• Collaborate closely with quality control project leaders and support new product introductions
• Assess, review, and approve quality records such as deviations, change controls, and corrective actions
• Author, review, and approve GMP-relevant documents and standard operating procedures