Quality Manager & EU RP

Job Description

• To act as the EU Responsible Person to uphold the activities listed in the Dublin Ireland WDA license and related business activities. To act as the key contact with HPRA to manage licensed requirements in line with Irish legislation and guidance.
• To fulfill the responsibilities of the EU GDP RP by ensuring:
  • The HPRA guidelines on Good Distribution practice are trained out and complied with.
  • the Operations do not compromise the quality of the medicines
  • an adequate Quality system is maintained
  • suppliers and customers are approved
  • oversight of the audit of the quality system and to carry out independent audits
  • that adequate records are maintained
  • all personnel are trained
  • customer complaints are dealt with effectively
  • disposition of returned, rejected, recalled or falsified product
  • full and prompt cooperation with marketing authorisation holders in the event of a recall.
  • RP required competencies obtained and refreshed routinely.
• To manage HSUK & HSIE Integrated Management System (IMS), to ensure processes are efficient and effective and are in compliance with applicable regulations and standards to maintain both QS and Product Licenses and approvals.
• To strategically manage the internal audit/self-assessment program for our range of product and activities across UK & Ireland, ensuring that audits are planned and performed by risk, in line with business needs, and auditors competencies are current and in place. Ensure that findings are addressed in a timely manner and areas where improvement is needed are elevated to the management review and line manager.
• To 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.
• Manage IMS quality system compliance obligations, certification, product storage and transportation requirements for all groups of product and service relationships. Ensuring agreements are implemented and maintained and audited to verify compliance status.
• Management of any critical suppliers and or outsourced service provision through maintenance of agreements, procedures and routine assessments.
• Manage the Risk Management process, ensuring that a program of risk assessment is conducted in line with business activities and risks identified. Ensuring that risks are ranked and elevated at appropriate intervals and associated corrective actions are routinely managed and documented.
• To manage the adverse events, recalls, field safety communications, and complaints relating to product and services, ensuring Q&R oversight of process and timeliness of actions needed.
• To manage the CAPA process ensuring CAPAs are documented and completed in a timely manner. Ensuring effectiveness of actions taken by completing follow up audits where deemed necessary.
• Establish, maintain and oversee a consistent QMS culture within HSUKH.
• To lead the Management Review Process, engaging the management team to uphold leadership responsibility and authority designated. Manage the periodic publication of quality policy and objectives and associated management of agreed KPIs.
• Compilation and management of IMS KPIs data and continuous improvement initiatives to increase the efficiency and effectiveness of the IMS and operational activities.
• Conduct, host and coordinate inspections of the organization and its critical suppliers, taking part in any due diligence targets and inspections as needed.
• To manage routine business operational requirements, Q&R key contribution in to processes and business strategies such as for tenders, environmental sustainability, continuous improvement projects and compliance programs.
• Ensure that the organization's regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.
• Contributing to product compliance initiatives and associated audits and verification activities needed to stay abreast of compliance requirements.
• Conduct and oversee quality/GDP/pharmacovigilance training and compliance communications. Monitor and verify the performance of the E-Learning programs where deemed appropriate and in line with our compliance obligations.
• Ensure that the interfaces between Regulatory and Quality and other departments are managed optimally.
• Other tasks and projects as needed