QA Specialist - Contract

Careerwise Recruitment

Munster, Cork

A QA Specialist is required by CareerWise Recruitment for a 2 year contract with our Cork based biotech client. Please contact Brian Flynn (Executive Search) for more information. THE ROLE: * Provide Quality leadership, direction and governance for the specific area of responsibility. * Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in the area of responsibility. * Approval/review of batch records. * For biopharma supporting role, provide support to the QP for batch certification of Biotech drug substance materials OR for pharma supporting roles, perform batch disposition activities (API material. * Review and approval of Trackwise change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches. * Review and approval of GMP documents associated with qualification and validation including, IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes. * Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents. * Approval of raw materials, intermediates and packaging components used in the manufacture of pharmaceutical products, using SAP. * Evaluation, audit and approval of 3rd party vendors of raw materials, intermediates and packaging components. REQUIREMENTS: * BSc (Hons) Micro, Engineering, Biochemistry, Chemistry, Analytical or a related discipline. * Ideally a minimum of 3 years QA experience. * Strong analytical and technical skills. * Problem solving skills - resolution and prevention measures. * Ability to network internally and externally to benchmark processes/systems. For further information please contact Brian Flynn (Executive Search) for more information. In Search of Excellence. Specialists in the recruitment of Senior Management, Operations, Technical/Engineering, Senior Supply Chain & Quality personnel, Supporting Business Demands & Growth since 1999. This job originally appeared on RecruitIreland.com.

2451 days ago