Quality Systems Specialist
We’re currently recruiting for an exciting opportunity with an award winning Pharmaceutical organization based in Cork. This is an excellent opening for anyone who is looking to join a leading multinational who are one of the best at what they do.
The candidate must have a broad knowledge of cGMPs and prior experience of working in HPRA/FDA regulated facility. The candidate must also build customer value through effective collaboration and influencing others, as well as consistently delivering on goals and objectives under minimal supervision.
The individual will be responsible for (some of the following):
• Internal Audit Program
• Management of the document management system- which can include supporting and advising Documentation Control administration personnel, as required
• GMP service providers program
• Managing the nonconformance system and CAPA process
• Quality agreement process
• Change control process and system
• Supporting site regulatory inspections where appropriate
• Supporting the site induction process
• Metrics and report generation from the quality systems
• Providing support, direction and training to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
• Partners with other departments to ensure that compliance systems are implemented in an efficient manner.
• Supports the development and management of GMP compliance systems through the following activities:
• Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
• Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
• Keeps abreast of regulatory compliance trends.
• The position of QS Specialist requires a third-level qualification (scientific/ engineering/ IT/ BIS discipline required)
• A minimum of 3-5 years’ experience within the biological and/or pharmaceutical/ medical device industry
• Demonstrated knowledge and application of industry regulations as they apply to systems including those of FDA, HPRA, EMEA and other authorities
• Experience of managing project groups or leading teams
• Experience with systems such as Trackwise and electronic documentation management systems will be a distinct advantage
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480