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Senior QA Specialist

Quality & Laboratory
Siobhán Lane
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Job Reference: JO-2011-65452_1604420235



· 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.

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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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