Sterile Manufacturing Team Member

CPL

Westmeath

Sterile Manufacturing Team Member An ophthalmic healthcare start up in Athlone is looking for a Sterile Manufacturing Team Member to join their team. This role will play a vital part in the initial start-up phase, as they will be responsible for preparing the filling equipment and operating process for the manufacturing facility, as well as developing and managing the batch numbers and documentation for the HPRA and FDA audits. Travel may be required within first 12 months. Responsibilities: Prepares the manufacturing equipment and facility for production batches. Participates in bi-annual media fill studies to maintain qualification status. Is trained to and follows the manufacturing procedures and systems of work designed to ensure the facility meets its safety, quality, delivery and cost goals. Is diligent in the completion and review of batch and related documentation required to support the manufacturing process. Assists the Quality organisation in In Process Checks and sampling of product and environmental conditions. Participates in continuous improvement teams and develops improvement ideas. Takes responsibility for manufacturing equipment and area condition and supports maintenance activity in the manufacturing area. Supports capital projects throughout equipment lifecycle. Supports product or process development projects and associated validation activities. Requirements: 5 years’ experience in a technical role within GMP. Certificate or Diploma Qualification in a GMP or technical subject would be a distinct advantage. Knowledge of aseptic manufacturing techniques and procedures. Capable of working with equipment automation systems required to operate those systems. God proactive approach & manner. Applicants should email their cv to peter.godwin@cpl.ie or call me on 01-9476227 for a confidential conversation. This job originally appeared on RecruitIreland.com.

2283 days ago