The Compliance Quality Specialist is responsible for activities related to Quality Management System (QMS) oversight, audit, and inspection follow up (CAPA) and will support readiness activities.
• Assist in projects that impact the Quality Management System. Report on progress against schedules, milestones and project goals, evaluate project resource needs and availability, identify and report gaps or project constraints, and develop solutions for successful implementation.
• Evaluate compliance with QA processes, Equipment Qualification, and Computer System Validation principles.
• Support all regulatory and customer quality audits.
• Gather, organize & analyze data to develop solutions & alternative methods of proceeding; execute continuous improvement projects to optimize operations to deliver process improvements
• Assist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.
• Identify compliance issues that require follow-up or investigation.
• Conduct internal investigations of compliance issues.
• Conduct internal investigations of customer complaints.
• Maintain documentation of compliance activities, such as investigation outcomes.
• Track compliance issues within all departments and ensure completion within defined timelines.
• Disseminate written policies and procedures related to compliance activities.
• Provide assistance in internal or external compliance reviews.
• Prepare management reports regarding compliance operations and progress.
• Monitor/Track compliance systems to ensure their effectiveness. Oversee internal reporting systems and inform employees about these systems.
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• BS/BA degree with 2 years of pharmaceutical industry experience in quality assurance/quality control or an equivalent combination of education and experience in a scientific or health-rated field
• Minimum 2 years directly related experience supporting compliance in a quality/compliance function or applicable compliance field.
• Knowledge of QMS and CAPA related tools or systems is preferred.
• Environmental monitoring or audit experience is an asset
• Experience with health authority inspections and inspection readiness activities preferred.
• Strong personal leadership with demonstrated competency interfacing with department lead is preferred.
• Working knowledge of applicable US FDA, USP and state board regulatory requirements and guidelines as applicable to the pharmaceutical industry.
• Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
• Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
• Flexible and able to adapt to company growth and evolving responsibilities.
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.