Quality Assurance Specialist

CPL

Limerick

Our Client works very closely with pharmaceutical & Biopharmaceutical companies and we are currently sourcing a QA Specialist to join their Team in Co Limerick. Function: The Quality Assurance Specialist participates in all Quality activities related to the business under the supervision of the Quality Manager. This role is responsible for maintaining the product specifications & COAs, raw material release, work order release, and other duties as required. He or she is required to be able to handle multiple tasks efficiently to ensure the quality activities that facilitate the production and customer requirements. Responsibilities : Carry out quality activities : Prepare specifications and certificate of analysis; Release specifications and certificate of analysis when required; Verify product information upon preparation of the certificate of analysis; Pre-approve raw material COAs; Release raw material and packaging materials; Review and approve release work orders. Help investigate quality complaints. Suggest improvements to SOPs. Coordinate with Quality Control for testing. Coordinate with Quality Assurance Assistant on the GMPBULK label request. Experience. Releasing or rejecting all products including excipients, buffers and process solutions. Establishing a system to release or reject raw materials, intermediates, packaging and labelling materials; Reviewing of all documentation pertaining to the batch release process including production records and QC documentation. Ensuring that nonconforming products and critical deviations are investigated and resolved in a timely manner; Specific Experience : 3 years of Quality Assurance Experience or equivalent; Technical writing ability; Knowledge of major Pharmacopoeial compendia; Knowledge of GMP, ICH and ISO guidelines. Education : Bachelor Degree or equivalent in Chemistry or a related science. If you have the above skills and experience please contact catriona.duggan@cpl.ie / Tele: 087 2419644.

819 days ago