LSC have a great contract opportunity for an Operations Compliance Specialist to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use. ABOUT THE PROJECT - KEY RESPONSIBILITIES: Manage the authoring & drafting of all types of Manufacturing Operations documentation. Specifications & associated forms in conjunction with the various departmental subject matter experts (SME) Support document updates and manage timelines for cross functional Projects. Act as a SME/Superuser on the Controlled Document System to facilitate the processing & approval of documents. Organise & Facilitate Document Round Table meetings with cross functional teams as required Mange and build Quality Veeva QMS metrics for Manufacturing Operations Coach & Train colleagues in Documentation System & GDP queries ABOUT YOU - ARE YOUR SKILLS A MATCH? Working knowledge in Regulations, GMP, GDP 2+ working within a regulated healthcare industry including a role in capacity of quality and compliance. Experience using Veeva is essential Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Sarina Abdulha at LSC on if you have any more questions about this opportunity! Skills: CAPA Compliance Deviation Handling Veeva GMP