QA Specialist is required for a contract role with LSC’s leading pharmaceutical client 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 site has added to its core functions over the years and is now a key decision maker in the company’s global supply chain. The site is going through a series of upgrades and investments in 2016/17 which will add to its current capabilities and strengthen its long term strategic plan.
The QA Specialist will be responsible for:
-Carrying out tasks and projects related to managing compliance activities during qualification and validation related to projects as required by GMP.
-Review and approval of change controls, nonconformance investigations, and protocols.
-Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the company Standard of Leadership behavior model.
-Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
Qualifications and Experience:
-Bachelors Degree in a scientific/technical discipline required
-A minimum of 2 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
-Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
-Experience in statistical sampling plan development.
Call Mairead in LSC 021 4777 329 for more details on this new QA Specialist role or apply directly via this advert.