· Co-ordinate regulatory activities including site master file, licences, declarations, desk top audits and other regulatory support.
· Manage and participate in GMP inspections by partners and regulatory authorities.
· Actively support the development/implementation and continuous improvement of the Quality Management Systems on site.
· Support Global Quality to ensure actions related to Quality Systems at the site are executed.
· Co-ordinate and deliver quality management review and site quality council presentations.
· Project lead for quality initiatives on site.
· Manage and deliver site wide GMP Training Policy & Programmes.
· Mentor and train Quality Support Professionals.
· Collate information and assist in the preparation of reports in relation to Annual Product Quality Reviews for all products manufactured on site.
· Liaise with other Department representatives to promote improvements in GMP and Quality standards.
· Keep abreast of latest developments from Regulatory Authorities
· Support and deliver continuous improvements using problem solving tools including root cause analyses and CAPA identification.
· Support change control process as required.
· Support the Review and Quality approval of documents as required.
· Third level qualification (NFQ Level 8 or higher) in Chemistry/Pharmacy/Biology/ Engineering or other appropriate discipline.
· Minimum of 5 years relevant experience within quality or manufacturing function in the Pharmaceutical industry.
· SAP and Veeva Vault experience (desirable).
· A positive mindset of Safety First
· A strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems is desirable.
· Ability to engage and influence key internal stakeholders so that they can deliver on improved performance.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists