QA Specialist required for a market leading, top Ten Biopharmaceutical company based in Cork. The Cork campus specializes in Tableting, 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 organization, who work to ensure their medicines are delivered on time and to the highest possible quality.Excellent opportunity for a QA Specialist to work in /as part of the QA Manufacturing and Facilities Support team with responsibility for ensuring QA review & approval of procedures and GMP deviations.
In this new position the QA Specialist will:
* Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements
* Reviews routine manufacturing and engineering documentation including batch manufacturing records
* Assists in the completion of Manufacturing related customer complaint investigations
* Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
The Successful Candidate will require:
* 4+ years of relevant experience in a GMP environment related field and a BS.
* 2 + years of relevant experience and a MS.
* Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
* Demonstrates working knowledge of quality assurance systems, methods and procedures.
Contact Siobhan Cummins at LSC on 021 4777 329 for more details, or apply directly via this advert.