QA Officer

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years, we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis, and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

**Location**: Birmingham, Solihull

**WHAT WE'RE LOOKING FOR**:
**Role Purpose**:
The Quality Assurance Officer ensures compliance with legislative requirements of maintain the company’s Wholesale License (WDA) by ensuring adherence 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, is responsible for maintaining our Wholesale License (WDA) by complying with GDP requirements of the role:
Ensuring that a quality management system is implemented and maintained.
Focusing on the management of authorised activities and the accuracy and quality of records.
Ensuring that initial and continuous training programs are implemented and maintained.
Coordinating and promptly performing any recall operations for medicinal products.
Ensuring that relevant customer complaints are dealt with effectively.
Ensuring that suppliers and customers are approved.
Approving any subcontracted activities which may impact on GDP.
Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
Keeping appropriate records of any delegated duties.
Deciding on the final disposition of returned, rejected, recalled, or falsified products.
Approving any returns to saleable stock.
Ensuring that any additional requirements imposed on certain products by national law are adhered to

Quality Management System (QMS)

Manage the local QMS and ensure that it meets all the requirements of the scope of the company’s business, as well as alignment with the corporate QMS where required. Ensure that the QMS meets requirement of ISO9001 and manage the relationship with the certification partner.

Manage and document all aspects of the QMS, and liaise with Management as required
Manage the storage, training, review and update of all Controlled Documents
Perform internal audits of business functions, in line with agreed schedule
Lead and document the Management Review process
Oversee significant changes as part of the Change Control process
Lead resolution of arising issues using the Corrective and Preventative Actions process

Learning Management System (LMS) Administration

Perform local administrative actions to maintain the UK users and training of the Company LMS: ComplianceWire.
Ensure all UK users and training items are correctly created and maintained
Liaise with UK staff to resolve any arising issues, and train new users
Liaise with global LMS manager over arising issues and training

Environmental Management System (EMS)
Implement a local EMS that meets ISO14001 standards
Information Security Management System (ISMS)Implement a local ISMS that meets ISO27001 standards

Additional Responsibilities

Regulatory Affairs

Manage the company medical device products on the Medical Device Register
Support Medical Affairs Manager and Corporate RA with arising issues
Attend monthly meetings with 3rd Party RA Partner

Pharmacovigilance

Support Medical Affairs Manager with arising issues
Attend monthly meetings with 3rd Party RA Partner and perform required arising actions

**Relationship with Others**:
Reports to Medical Affairs ManagerWorks closely with HQ Quality Department, Commercial Operations, Finance, Supply Chain team.

**Disclaimer**:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.