The successful candidate will be responsible for the following:
Release or rejection of API's. Final review of completed batch production records and laboratory control records of all critical steps before release of API for distribution as defined in site procedure. Approving all specifications and master production instructions. Ensuring that critical deviations are investigated and resolved. Ensuring that quality related complaints are investigated and resolved. Ensuring all product quality reviews (PQR's) are completed in a timely manner. Ensuring that all procedures related to product manufacture are kept up to date and accurate, and that methods specified for product manufacture and testing are properly validated. Ensuring that all staff receives ongoing training on cGMP as prescribed in company procedures. Monitoring company performance with respect to its manufacturing authorisations and reporting as required to the Plant Director, and external agencies. Maintaining good communication channels with the HPRA and other relevant regulatory agencies.
Ensuring that all raw materials used in production at Company come from approved suppliers. Ensuring that all raw materials are tested in QC prior to use in accordance with company procedures. Maintaining systems to release or reject raw materials, intermediates, and packaging materials. Ensuring that there is stability data to support retest or expiry dates and storage conditions on API's and /or intermediates where appropriate.
Applications are invited from candidate with relevant experience gained within an API facility.
For more information and to apply for this role please call Stephanie on 1 or e-mail
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1