Job Details
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
YOUR PROFILE :
• Sufficient experience and qualifications in GDP and QMS
• Good knowledge of the administrative tasks
• Good competencies in contrast media and medical devices are an asset
• Fluent in English
• Analytical skills and attention to detail
• Ability to work independently and as part of a team
• Self-motivated and responsible
Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. or you can also call this number +19843443717
