Quality Assurance Manager

2 weeks ago

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

Overview

Henry Schein UK Holdings 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 quality and compliance of our products and services.

Key Responsibilities

  • EU Responsible Person
    • Ensure compliance with the Dublin Ireland WDA license and related business activities.
    • Manage licensed requirements in line with Irish legislation and guidance.
  • EU GDP RP
    • Ensure the HPRA guidelines on Good Distribution practice are trained out and complied with.
    • Oversee the quality of medicines and maintain an adequate Quality system.
    • Approve suppliers and customers.
    • Conduct independent audits and maintain records.
    • Train personnel and handle customer complaints effectively.
    • Dispose of returned, rejected, recalled, or falsified product.
    • Cooperate with marketing authorisation holders in the event of a recall.
    • Obtain and refresh RP required competencies routinely.
  • Integrated Management System (IMS)
    • Manage the IMS to ensure processes are efficient and effective.
    • Ensure compliance with applicable regulations and standards.
    • Maintain QS and Product Licenses and approvals.
  • Internal Audit/Self-Assessment
    • Manage the internal audit/self-assessment program.
    • Ensure audits are planned and performed by risk.
    • Ensure auditors' competencies are current and in place.
    • Address findings in a timely manner.
  • IMS Quality System Compliance
    • Manage IMS quality system compliance obligations.
    • Certify product storage and transportation requirements.
    • Ensure agreements are implemented and maintained.
  • Risk Management
    • Manage the Risk Management process.
    • Conduct a program of risk assessment in line with business activities.
    • Rank and elevate risks at appropriate intervals.
    • Manage corrective actions.
  • Adverse Events, Recalls, and Field Safety Communications
    • Manage adverse events, recalls, and field safety communications.
    • Ensure Q&R oversight of process and timeliness of actions needed.
  • CAPA Process
    • Manage the CAPA process.
    • Document and complete CAPAs in a timely manner.
    • Ensure effectiveness of actions taken.
  • QMS Culture
    • Establish, maintain, and oversee a consistent QMS culture.
  • Management Review Process
    • Lead the Management Review Process.
    • Engage the management team to uphold leadership responsibility and authority.
    • Manage the periodic publication of quality policy and objectives.
    • Manage agreed KPIs.
  • IMS KPIs and Continuous Improvement
    • Compile and manage IMS KPIs data.
    • Initiate continuous improvement initiatives.
  • Inspections and Due Diligence
    • Conduct, host, and coordinate inspections of the organization and its critical suppliers.
    • Participate in due diligence targets and inspections as needed.
  • Regulatory Affairs
    • Ensure regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.
  • Product Compliance Initiatives
    • Contribute to product compliance initiatives.
    • Participate in associated audits and verification activities.
  • Quality/GDP/Pharmacovigilance Training
    • Conduct and oversee quality/GDP/pharmacovigilance training and compliance communications.
    • Monitor and verify the performance of E-Learning programs.
  • Interfaces between Regulatory and Quality
    • Manage interfaces between Regulatory and Quality and other departments.

About Henry Schein

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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