Role DescriptionProduct complaints investigations are about improving the patient’s experience with products by providing timely, thorough, and patient focus investigations which identify and implement corrective and preventative actions that promote a culture of continuous improvement and quality.
You have a quality background, both in Education (Pharmacist, biomedical, bio-engineering, biotechnology) and you have worked for a few years in a pharmaceutical environment, ideally a manufacturing or operations plant. You are able to maintain oversight on different projects and dive into details when required. Working in teams and communicating effectively with all kind of stakeholders is crucial in this role.
// Lead and manage product complaint investigations, product security investigations, safety quality investigations, trend investigations and consolidated investigations for commercial products // Applies analytical skills to evaluate complex situations using multiple sources of information // Execution of regulatory and SOP requirements // Anticipates and prevents potential issues with regulators // Partner with corporate product quality surveillance, assessors from other sites and contracted supplier/ manufacturers to resolve product complaints investigations // Provides guidance and technical advice // Evaluates subject matter expert assessments // Escalates potential Quality issues to Management // Act as site representative in the product complaint network // Attend Network meetings and provide meaningful input and expertise // Support Network activities and continuous improvement initiatives // Perform data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner // Liaise with Operations, Warehouse, Packaging Development and Engineering to provide information on complaints for process improvement initiatives // Train affiliate staff in complaint handling procedures // Support audits (internal and third party) and Regulatory Inspections by presenting the product complaint system and records and follow-up on commitments
RequirementsWho are we looking for?
// You have a master’s degree (e.g. in Pharmacy, Industrial Pharmacy, Bio-engineering,…) and 3+ years of experience in pharmaceutical industry // Fluent in English // You have sound knowledge of Quality Assurance principles, Good Manufacturing Practices and Good Distribution Practices // Computer literacy
Preferred Requirements // You have experience in Quality Assurance, including handling product complaints investigations // Track record of success in international working environment // You have experience in leading cross functional teams // Experience leading investigation in Operations (Root Cause Analysis)
Other informationSounds like an interesting opportunity for you? Let me know!
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ria Bos.