QUALITY MANAGER/QP
THE ROLE:
* Being responsible for disposition of medicinal product
* Coordinating QA resources assigned to functional area to meet goals
* Manage the QMS, ensure the QMS is fit for purpose, overseeing the team in making changes as necessary approving SOPs and Quality System documents.
* Manage communications with and represent the company during HPRA Inspection.
* Support HPRA inspections and prepare written responses to inspections.
* Prepare and approve HPRA variations.
* Provide QA expertise and manage any Quality issues that arise to closure.
* Support internal compliance audits of operations.
* Provide QA oversight and expertise for New Product Introductions
* Oversee the team in the review and approval of Non-Conformances (NC), CAPA, change controls and complaints.
* Organise annual review of suppliers.
* Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release.
* Assist in the preparation, review and regular update of technical agreements with licensees and 3rd party contractors.
* Organise and schedule periodic review of QMS and operational procedures for regulatory compliance through internal audit system.
* Implementation of the Self Inspection/Internal Quality Audit program.
* Overall responsibility for reporting and investigation of non-conformances and identification of CAPAs to ensure continuous improvement of the QMS and operational procedures.
* Escalation of issues as appropriate.
* Participating in cross functional teams as Quality/Qualified Person representative
* Providing advice and direction to other company departments on quality and regulatory issues
The QP must be eligible to act as a European Qualified Person (QP), certifying products in compliance with EU2019/6 and Annex 16.
REQUIREMENTS:
* BSc (Hons) in Science or equivalent
* Relevant experience: 1 year (required)
* Certification to comply with EU2019/6 and Annex 16 (required)
* Work authorisation: Ireland (required)
Job Type: Full-time
Additional pay:
* Yearly bonus
Benefits:
* Company pension
* On-site parking
* Sick pay
Schedule:
* Monday to Friday
* No weekends
Work Location: In person
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