Regulatory compliance specialist

Our client, a company firmly etablished, offering ready to use solutions of manufacturing and packaging for the pharmaceutical, nutraceutical, alimentary and cosmetic industries is currently looking for a regulatory compliance specialist.

Nature of position

In collaboration with the regulatory compliance director, you will have as main responsibility to ensure the improvement of the quality system process, in relation to procedures, trainings, internals and externals audits, suppliers management, CAPA as well quality reviews, while providing a support to the regulatory compliance director. As such, you will :

• Maintain the quality system at high level of compliance while considering the processus improvement and operational constraints ;
• Plan/carry out supplier assessments( including site audits) ;
• Set up quality agreements with suppliers ;
• Maintain up to date the records of approved / accredited suppliers ;
• Develop a schedule for internal audits in accordance with existing regulations and norms and perform and / or coordinate those audits ;
• Train the certified auditors and ensure they prepare an audit report in time, and make the necessary recommandations, in addition to assess the performance of the skilled auditors ;
• Monitor the trends and suggest corrective or preventive actions (CAPA) if needed ;
• Manage the CAPA with their monthly actions and implementations follow-up ans measure the overall effectiveness of the CAPA ;
• Carry out the annual quality review by a qualitative and quantitative data analysis and produce the final report with conclusions / recommendations for improvement ;
• Provide support to the regulatory compliance department ;
• Prepare, present, document and evaluate trainings on standard operating procedures (PON), on good manufacturing practices and on procedural / appendix changes or implementation of new procedures / appendices ;
• Perform every other tasks compatible with your functions.

Required qualification

• 1st cycle of university degree in sciences (chemistry, biology, biochemistry, etc.), engineering or any other relevant field ;
• Minimum 10 years of relevant experience ;
• Have 5 years of experience in audit as an audited entity and 3 years as a certified auditor and show experience in supplier’s audit ;
• Bilingualism in french and english ( written and spoken) ;
• Proficiency in pharmaceutical current norms (BPF/GMP’s, FDA, EU, etc.).

Education / training

Bachelor in biochemistry, Bachelor in biology, Bachelor in chemical engineering , Bachelor in chemistry

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