Quality 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. They now need a dedicated Quality Specialist to take charge of their Internal Audit and QMS function. About the Job: You will be responsible for the execution and maintenance of key Quality documents including coordination, implementation, and daily management of documentation distribution and maintenance of documents required for manufacturing, testing, and packaging of product. Other key accountabilities include: issuance of logbooks, request for reviews, execution and maintenance batch record. Essential Functions: Reviews & monitors NC/NOI/CAPA`s to closure. Reviews & monitors SOP`s and Change Controls actions through to closure. Generates and issues Batch Records to production. Retrieves executed Batch Records from QA. Maintains files stored in document room and readily retrieves upon request. Maintains, stores and controls document. Maintains hard copy change controls. Maintains Master Formulation Documents, Packaging Orders and specifications. About you: Level 8 Qualification in Quality/Engineering related discipline. Minimum 3+ years in a QA, QMS, Quality/ValidationEngineering, or similar role within the Medical Device or Pharmaceutical Industry. Ability to multi-task and flexibility to accommodate changing priorities. Strong process and regulatory knowledge. Customer service oriented. Strong communicator with the ability to influence. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

2041 days ago