QA Engineer - County Wicklow. This position is being offered as a 12 months' fixed-term contract. Duties and responsibilities: The ideal candidate will have engineering or science related background with a solid understanding of cGMP guidelines as they pertain to API pharmaceutical manufacturing, with an emphasis on quality assurance, facility, equipment and process qualification activities. You will be responsible for managing the technical quality aspects associated with API manufacturing and regulatory requirements for the manufacture of clinical and commercial API's and other solutions. Areas of emphasis include but are not limited to process validation and capability assessments, facility alarm management (facility temp. pressure, humidity), periodic review of validated systems, trend analysis of facility and utility control data. Interested applicants should have: Degree in an Engineering or Science related discipline. At least 2 years' pharmaceutical, laboratory, manufacturing or Quality Engineering related experience. Previous experience in Biopharmaceutical manufacturing facility & quality systems. Thorough knowledge of cGMP's and SOP's related to Quality. Good working knowledge of associated industry and regulatory guidance documents: FDA guidelines, ISO standards, ASTM standards, etc. Excellent knowledge/understanding of protocol acceptance criteria and capable of determining appropriate Corrective action/Preventative Action (CAPA. This job originally appeared on RecruitIreland.com.
70 days ago