Quality Engineer

Quality Engineer

Requirements

• Bachelor’s degree in Science or Engineering and a minimum of 9 years experience working in a regulated, cGXP environment or Master’s degree and a minimum of 6 years experience working in a regulated, cGXP environment
• Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation
• Demonstrated knowledge of cGXP regulations and guidance
• Demonstrated experience with change control, CAPA and deviation quality systems
• Demonstrated experience with project management
• Demonstrated proficiency in critical thinking and technical writing
• Extensive experience in ensuring compliance with local, national, and international pharmaceutical regulations and standards
• Proven experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up

Responsibilities

• Developing, implementing, and maintaining effective Quality Management Systems (QMS)
• Ensuring that the site complies with all laws, regulations, and standards applicable in the pharmaceutical industry
• Ensuring the company is always prepared for inspections by regulatory bodies for topics related to dossier compliance
• Provide training and guidance to employees on compliance topics from global Sanofi standards applicable for the site
• Participating in regulatory inspections and audits (internal and external bodies)
• Identifying compliance risks and contributing to the development of strategies for mitigation
• Ensuring any compliance incidents are properly reported and investigated with the implementation of appropriate corrective actions
• Overseeing the maintenance and management of compliance-related documentation
• Identifying and leading continuous improvement initiatives to enhance compliance
• Perform the Quality Assurance review and approval of change controls, deviations, laboratory investigations, and CAPAs to ensure that they meet the requirements of Sanofi standards and procedures, and are clearly and appropriately justified
• Perform product complaint investigations
• Work closely with manufacturing, quality and support groups to resolve Quality System requirements within agreed timelines
• Work closely with manufacturing, quality and support groups to develop effective CAPA
• Generate and present assigned metrics at the required frequency which drive accountability and delivery of targets
• Participate in and/or lead formal risk assessments
• Review and provide guidance for proposed and existing changes through the formal change control process as it applies to validated processes, equipment and test methods

Preferred Qualifications

• In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH)
• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions
• Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders
• Proficiency in managing multiple compliance projects simultaneously, ensuring timely completion and adherence to standards
• Keen attention to detail to ensure accuracy in compliance documentation, audits, and reports
• Experience with SMS, LEAN (problem solving/use of Lean tools) or comparable continuous improvement systems
• Experience with root cause analysis tools and gap identification