QA Specialist – II 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 – II will:
o Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
o Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
o Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
o Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
o Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
TheQA Specialist – II will require:
o 3+ years of relevant experience in a GMP environment related field and a BS or BA.
OR Some years of relevant experience and a MS.
o Specifically for this role it is required that the QA Specialist act as the QA representative on the MES upgrade Project, previous experience of Computer System Validation whilst advantageous is not mandatory
o Prior experience in pharmaceutical industry is preferred.
o Demonstrates proficiency in Good Manufacturing Practices (GMPs).
o Demonstrates proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on validation and engineering requirements.
Contact Mairead at LSC on 021 4777 329 for more details, or apply directly via this advert.