Quality Assurance Specialist Job Description
In this role, you will be responsible for ensuring the company's products meet the required Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. You will work closely with the Quality Manager and other key stakeholders to maintain and enhance the quality systems.
Responsibilities:
* Support Compliance Efforts: Assist the Quality Manager and Qualified Person in ensuring adherence to GMP, GDP, Quality Systems, and both local and international regulations.
* Develop and Implement Quality Procedures: Collaborate with operational staff to define and regularly update Quality Procedures, ensuring alignment with regulatory and industry standards.
* Conduct Internal Audits: Participate in the auditing of GMP/GDP systems, ensuring corrective actions are effectively planned, implemented, and assessed for long-term effectiveness.
* Train Personnel: Educate personnel on updated GMP/GDP documentation and ensure understanding of the Quality Management System (QMS).
* Manage Quality Reviews: Gather and organize data for presentations and discussions at Quality Review Board meetings.
* Investigate Incidents: Document, investigate, and report any deviations or incidents to the Quality Manager and Qualified Person, helping to resolve issues promptly.
Requirements:
* Education: Bachelor's degree in a scientific discipline is preferred.
* Experience: A minimum of 3 years' experience in quality system roles within FDA and/or EU regulated environments, ideally in manufacturing or distribution.
* Regulatory Knowledge: Understanding of local regulations and industry best practices related to quality and compliance.
* Attention to Detail: Strong organizational skills and a high level of accuracy in handling technical and regulatory information.
* Communication: Strong verbal and written communication skills in English, with proficiency in report and policy writing.
* IT Skills: Proficient in Microsoft Office and relevant job-specific computer applications, including electronic validation systems.