Quality Systems Specialist is required for a leading pharmaceutical company in Cork. Our client specialises in the manufacture of small molecule APIs in three production facilities on site, one of which is sterile. This site has been producing APIs for over 35 years in Cork and has developed a reputation as being innovative, adaptive and having a clear strategic vision.
The Quality Systems Specialist will be responsible for:
o Providing support, direction and training to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
o Partners with other departments to ensure that compliance systems are implemented in an efficient manner.
o 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 Quality System Specialist requires:
o A third-level qualification (scientific/ engineering/ IT/ BIS discipline required)
o A minimum of 3-5 years’ experience within the biological and/or pharmaceutical/ medical device industry
o Knowledgeable of FDA/EMEA regulatory requirements
o Demonstrated knowledge and application of industry regulations as they apply to systems including those of FDA, HPRA, EMEA and other authorities
Call Regina in LSC 021 4777 329 for more details on this new Quality Systems Specialist role or apply directly via this advert.