QA 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 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:
o 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.
o Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
o Supports the management of GMP compliance systems through the following activities: Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
o Carries out tasks related to the administration of project and site nonconformance management systems:
o Reviews and/or approves nonconformance investigations and their associated documentation.
o Manages entry of nonconformance records into the appropriate electronic system.
The QA Specialist requires:
o Bachelors Degree in a scientific/technical discipline required
o A minimum of 2 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
o Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
o Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
Call Mairead in LSC 021 4777 329 for more details on this new QA Specialist role or apply directly via this advert.