Quality Assurance Manager

1 week ago

Gillingham, Kent, United Kingdom Henry Schein Full time
Job Description

Henry Schein is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance in our operations.

Key Responsibilities:
  • EU Responsible Person: Uphold the activities listed in the Dublin Ireland WDA license and related business activities.
  • Quality System Management: Ensure the HPRA guidelines on Good Distribution practice are trained out and complied with, and that operations do not compromise the quality of medicines.
  • Regulatory Compliance: Manage licensed requirements in line with Irish legislation and guidance, and ensure that all personnel are trained.
  • Integrated Management System (IMS): Manage and maintain IMS, ensuring that all processes and activities within its scope of activity are maintained and in compliance with the business strategic approach and regulatory requirements.
  • Risk Management: Conduct a program of risk assessment in line with business activities and risks identified, and ensure that risks are ranked and elevated at appropriate intervals.
  • Adverse Events and Recalls: Manage adverse events, recalls, field safety communications, and complaints relating to product and services.
  • CAPAs: Manage the CAPA process, ensuring CAPAs are documented and completed in a timely manner.
  • Management Review: Lead the Management Review Process, engaging the management team to uphold leadership responsibility and authority designated.
  • IMS KPIs: Compile and manage IMS KPIs data and continuous improvement initiatives to increase the efficiency and effectiveness of the IMS and operational activities.

Henry Schein is committed to the principle of equal opportunities in employment in all spheres of its operation. We strive to operate a policy of equal opportunity and not discriminate against any person based on gender, race, colour, nationality, ethnic or national origin, religion, sexual orientation, marital status, disability, age, or any other characteristic protected by law.

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