Quality Assurance Associate

Brightwater

Tipperary

This is a great opportunity to join a start-up site in Tipperary with one of the worlds biggest generic pharma manufacturers. This is a rapidly expanding company who are dedicated to high end, speciality medications. At their state-of-the-art facility you'll be part of a high performing team. Reporting to the QA Lead, you will be working closely with the business functions to provide QA support. Responsibilities: Review and approval of Manufacturing and Cleaning Batch Documentation and associated equipment logbooks in accordance with cGMP. Batch disposition and preparation of certificates of analysis. Pre-operative and routine inspections of the plants and facilities – shop floor presence. Coordination of trend data for plants on a monthly basis. Participation in the internal audit team. Review and approval of GMP SOP's. Review of change controls. Participate in GMP reviews. Additional Responsibilities: Preparation, update and delivery of training including preparation of courses and assessments, Compilation of Process and Cleaning validation protocols and reports. Communicate with all departments on site on a regular basis to ensure timely approval, use and shipping of product. High level of interaction with the various functions on site: Manufacturing, QA and Supply Chain. Qualifications/Experience: Diploma in Quality Systems or a science related discipline. At least 2 years pharmaceutical, ideally in an IPQA role, or an Inspections role within Operations. Able to demonstrate excellent time management and organizational skills along with a proven ability to multi-task. Excellent interaction, communication and presentation skills are necessary to be successful in the role. Some experience in continuous improvement activities and project management would also be advantageous. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

2231 days ago