QA Validation Specialist

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. You will be required to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. Essential Duties and Responsibilities. Executes and reviews Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities as QA Validation. Generates and executes project validation plans and validation master plans. Co-ordinates with manufacturing / engineering personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities. Investigates any deficiencies related with qualification activities and determines corrective actions. Preparation and review of SOPs and Drawings as related to validation. Review and approval of calibration and PM activities (e.g. schedules) and Work orders. Experience and Qualifications: Degree in Science or Engineering. 5 years of experience in a Pharma or combination product environment. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

2232 days ago