QA Officer - UK

The provided job description covers comprehensive responsibilities and requirements for the Quality Assurance Officer role, including compliance, management systems, regulatory affairs, and candidate profile. However, the formatting can be improved for clarity and readability by organizing sections with appropriate headings and lists, and removing irrelevant or redundant information such as the social network login prompt. Here is a refined version with better structure:

Job Title: Quality Assurance Officer

The Quality Assurance Officer ensures compliance with legislative requirements to maintain the company’s Wholesale License (WDA) by adhering to Good Distribution Practice (GDP). Manages the UK Quality Management System (QMS) and reports to the Medical Affairs Manager.

Your Role

Good Distribution Practice (GDP)

As the registered Responsible Person for GDP with the MHRA, responsible for maintaining our Wholesale License (WDA) by:

• Implementing and maintaining a quality management system
• Managing authorized activities and ensuring record accuracy and quality
• Implementing and maintaining training programs
• Coordinating recall operations for medicinal products
• Handling customer complaints effectively
• Approving suppliers and customers
• Approving subcontracted activities impacting GDP
• Performing regular self-inspections and implementing corrective actions
• Keeping records of delegated duties
• Deciding on the final disposition of returned, rejected, recalled, or falsified products
• Approving returns to saleable stock
• Adhering to additional legal product requirements

Quality Management System (QMS)

Manage the local QMS to meet the company's scope and align with the corporate QMS, ensuring compliance with ISO9001 and managing certification relationships.

• Manage and document all QMS aspects
• Manage storage, training, review, and updates of controlled documents
• Conduct internal audits and lead management reviews
• Oversee change control processes and corrective actions

Learning Management System (LMS) Administration

Maintain UK user and training data in ComplianceWire, resolve issues, and liaise with global LMS management.

• Create and maintain user profiles and training records
• Support UK staff and train new users
• Coordinate with global LMS team

Environmental and Information Security Systems

Implement local EMS meeting ISO14001 standards and ISMS meeting ISO27001 standards.

Additional Responsibilities

Regulatory Affairs

• Manage medical device products on the Medical Device Register
• Support Medical Affairs and Regulatory Affairs teams
• Attend and act on monthly meetings with third-party RA partners

Your Profile

• Experience and qualifications in GDP and QMS
• Knowledge of administrative tasks
• Contrast media and medical device experience is a plus
• Fluent in English
• Strong analytical skills and attention to detail
• Ability to work independently and in teams
• Self-motivated and responsible

Guerbet is an Equal Opportunity Employer, committed to diversity and inclusion. We do not discriminate based on age, disability, ethnicity, gender, religion, sexual orientation, or other protected categories. For inquiries, call +19843443717.