QA Specialist

Life Science Consultants Ltd

Cork

QA Specialist required for a market leading, top Ten Biopharmaceutical company based in Cork . The Cork campus specialises in Tabletting, Solid Dose, Packaging & Distribution of a range of products. The site is a strategically important site within their global operations and has grown consistently since its founding almost 15 years ago. Today the site is responsible for Tablet manufacturing, quality control, packaging, and the release and distribution of the company's products in the EU and other international locations. The Cork campus is a team focused organisation, who work to ensure their medicines are delivered on time and to the highest possible quality. In this new position the QA Specialist will: o Performs a variety of activities to ensure compliance with applicable regulatory requirements. o Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs. o Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues. o Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. o May support in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products. The QA Specialist will require: o 3rd level degree in a relevant disdipline. o 2 years of relevant experience in a GMP environment related field. o Demonstrates working knowledge of current Good Manufacturing Practices (GMPs. o Demonstrates knowledge of FDA / EMEA standards and quality systems. o Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards. Contact Amparo at LSC on 021 4777 329 for more details, or apply directly via this advert. This job originally appeared on RecruitIreland.com.

2496 days ago