Role DescriptionWithin this exciting company, you will:
• Ensure that (new) regulations are implemented in the company • All compliance issues including local quality systems in GMP and GDP and Regulatory matters (authorizations, supply…). • Ensure the quality aspects through participation in cross-organisational projects, reporting systems and meetings (product maintenance, change controls, deviations, complaints, recall, …) • QA function with respect to external suppliers and partners directly connected to the manufacturing site (e.g. qualification, audits, quality agreements, evaluation) • To promote a good knowledge level in the QA area by setting up a training program for the Quality Unit personnel
Responsibilities• You will prepare and review the documents linked to the implementation of the Quality Policy and the Quality Management System (SOPs, WI’s…). • You will implement correct written procedures, in conformity with the internal and international guidelines. • You will guarantee that a good documentation system is in place. • You will participate in solving different problems and support for corrective actions in the GxP areas. • Organisation and performance of Quality Management Review. • Organisation and performance of self-inspections in GxP relevant areas. • You will report to the Global Operation Quality: Monthly reporting, inputs to annual report KPIs and Product recall reports. • QA function with respect to external suppliers such as qualification, audits and quality agreements. • You will provide help for the establishment of Quality Agreement with the clients partners. • Act as expert in quality processes tracked in EQMS. • Participate in the periodic review of the Quality Manual. • Monthly reporting to Global • Maintain your knowledge level by suitable training: • Participate in initial and continued training and qualification activities as required for the job function • Complete training within the specified timeframe • Complete all required training prior to performing assigned regulated job activities and work under supervision until qualified to work independently • Document completed training per local requirements • Seek clarification as needed to ensure understanding of job requirements and applicability of training completed • Demonstrate knowledge or skills gained from completion of required training and qualification • Participate in retraining when there is a knowledge or skill gap and when required refresher training is offered by client
Requirements• Experience as Quality Assurance Officer or Manager • Fluent in English and Dutch (both verbal and written), French is a plus • Ability to work easily with digital platforms • Specific and current knowledge of international rules and guidelines for the pharmaceutical industry, Quality Management Systems, GMP & GDP and Regulatory Affairs. • Experience in a pharmaceutical environment is required • Autonomous and assume responsibilities • Analytical mindset • Decision making based on scientific aspect and risk evaluation
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Greg Silberstein.