Over de functie
The Compliance QA Assistant supports the Compliance QA Specialist in activities related to Quality Management System (QMS) oversight, audit, and inspection follow up (CAPA) and will support readiness activities.
- Assists in projects that impact the QMS. Report on progress against schedules, milestones and project goals. Notify Specialist on project resource needs and availability, identify and report gaps or project constraints.
- Support all regulatory and customer quality audits.
- Gather, organize & present data to assist in the development of solutions and new processes.
- Assist and execute continuous improvement projects.
- 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.
- Assist in internal investigations of compliance issues.
- 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.
Maak het verschil
- High School Diploma (or equivalent) with 1-2 years of pharmaceutical industry experience. Associates or bachelor’s degree preferred.
- Pharmaceutical experience within a Quality department preferred.
- Knowledge of QMS and CAPA related tools or systems is preferred.
- Experience with Microsoft Office.
- 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 tasks.
- Strong interpersonal skills and the ability to work effectively across multiple departments.
- Flexible and able to adapt to company growth and evolving responsibilities.
Wat bieden wij?
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.