Quality Assurance Specialist

2 months ago

Solihull, Solihull, United Kingdom Guerbet Full time
Job Description

About the Role:

The Quality Assurance Specialist will be responsible for ensuring compliance with legislative requirements and maintaining the company's Wholesale License (WDA) by adhering to Good Distribution Practice (GDP). This role will also involve managing the UK Quality Management System (QMS) and reporting to the Medical Affairs Manager.

Key Responsibilities:
  • Good Distribution Practice (GDP):
    • Ensure that a quality management system is implemented and maintained.
    • Focus on the management of authorized activities and the accuracy and quality of records.
    • Ensure that initial and continuous training programs are implemented and maintained.
    • Coordinate and promptly perform any recall operations for medicinal products.
    • Ensure that relevant customer complaints are dealt with effectively.
    • Ensure that suppliers and customers are approved.
    • Approve any subcontracted activities which may impact on GDP.
    • Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
    • Keep appropriate records of any delegated duties.
    • Decide on the final disposition of returned, rejected, recalled, or falsified products.
    • Approve any returns to saleable stock.
    • Ensure 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 the requirements 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.
    Requirements:
    • Qualifications and Experience:
      • Sufficient experience and qualifications in GDP and QMS.
      • Good knowledge of administrative tasks.
      • Good competencies in contrast media and medical devices are an asset.
    • Skills and Abilities:
      • Fluent in English.
      • Analytical skills and attention to detail.
      • Ability to work independently and as part of a team.
      • Self-motivated and responsible.

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