Job Description
A vacancy for a Quality Specialist has arisen in a Pharmaceutical company with its Head Office in Dublin. This opportunity will suit a person interested in working with a small team in a rapidly growing company in a dynamic environment, who will enjoy learning on the job. Some travel, mainly to the US can be expected. This is a broad role where the incumbent will have the opportunity for involvement across the whole quality system.
The Quality Specialist is responsible for the development and maintenance of the Quality Management System (QMS) and associated documentation whilst meeting the regulatory and quality standards in the areas of operation.
Reporting to: Vice President, QA/RA
Key Responsibilities:
- Maintenance of the Quality Management System
- Management of deviations, CAPAs and change controls associated with commercial products
- Preparation of batch release documentation for approval
- Operation and maintenance of quality documentation system
- Preparation and delivery of training as required by the QMS
- Reporting of quality metrics and participating in periodic review of QMS and management review
- Preparation of annual reports, APRs and PADERs
- Conducting internal and external audits
- Management of supplier evaluation and approval
- Support for artwork changes
- Preparation for and involvement in regulatory inspections
- Preparation of supporting documentation for CMC Regulatory Filings
- Management and coordination of investigations related to adverse events and customer complaints
Skills & Qualifications:
- Scientific or technical qualification (Minimum NFQ level 8)
- Professional written and oral communication skills including presentations
- Good planning and organising skills
- Adept at and comfortable with statistical analysis
- Strong understanding of good quality assurance systems and GMP
- Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
- Previous experience with electronic document management systems
For further information on this QA Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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