Quality Assurance Specialist

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Exciting Opportunity: Quality Assurance Officer

Fantastic opportunity for a Quality Assurance Officer to join a dynamic, mid-sized pharmaceutical company. This is a great time to join, as they are expanding their product portfolio and offering excellent opportunities for career progression.

As part of a high-performing Quality Assurance (QA) and Pharmacovigilance (PV) team, you will report directly to the QRVI Director and play a key role in supporting the company’s growth and quality objectives.

Key Responsibilities:

• Enhance the Pharmaceutical Quality System: Continuously drive improvements to ensure high product quality and regulatory compliance.
• Ensure Compliance with European GDP Guidelines: Oversee the compliance of the affiliate with Good Distribution Practice (GDP) for all relevant products.
• Documentation Review & Approval: Review and approve documents impacting QA activities to ensure alignment with regulatory standards.
• Training Management: Oversee, manage, and report on the Electronic Learning Management System (LMS) to ensure all training requirements are met.
• Electronic Documentation Management: Supervise and report on the management of the Electronic Documentation Management System (EDMS).
• Electronic Reporting & Product Database Management: Oversee and report on the management of the Electronic Reporting System and Product Database Management System.

Key Requirements:

• Strong understanding of Quality Systems Management, Good Distribution Practice (GDP), and Regulatory & Pharmacovigilance legislation.
• Practical experience in process development, improvement activities, and quality systems to support continuous improvement.
• Experience in process mapping and creating process documentation.
• A flexible, adaptable approach to changing circumstances and new opportunities, with the ability to drive and facilitate change.
• Excellent attention to detail and organizational skills.
• Minimum of 2 years’ experience in a Quality Assurance role.