On behalf of our client, a pharmaceutical company, we are currently recruiting for a Senior Quality Specialist. This is a permanent full time role. The office is based in South Dublin but there is good flexibility to work from home a couple of days a week.
Responsible for setting up, maintaining and the continuous improvement of the quality management system as MAH.
- Acts as the primary quality lead and management oversight for Quality all quality related activities on behalf of the Marketing Authorisation Holder
- Development, management and implementation of the Quality Management System, including GMP & GDP systems, processes and SOP preparations.
- Implemention and maintainance of Quality and Distribution Agreements with third parties, covering GMP, GDP and GCP acticvities
- Providing quality advise to stakeholder departments in relation to GxP, covering commercial and development activities
- Review and approve third party QMS documentation to ensure compliance with product authorisations and GxP requirements
- Co-ordinate and review change controls
- Manage and support third party audit management including CAPA
- Review and assessment of deviations
- Manage and review/approve the annual product review process
- Support the preparation of Quality Management Reviews and Quality KPIs/metrics information.
- Review documents assocaited with the manufacture and distribution of products manufactured by third parties, including, but not exclusively, batch manufacturing records, analytical records, validation activitity
- Manage and participate in third party audits
- Maintain tracking system for QMS documentation
- Quality review of complaints
- Carry out training and communication activities with staff to ensure adequate understanding of Quality Systems and regulatory requirements
- Drive continuous improvement initiatives to enhance the MAH quality sytem and product quality ensuring compliance to governing regulations.
Act as the quality contact to customers and competent authority
- Degree in related Scientific Discipline
- Min 3 years experience in a similar role
- Solid experience in QMS
- Ability to make quality decisions
For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 278467