LSC have a great contract opportunity for a Technical Writer 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. If you have 2 years of experience in a GMP regulated environment and are ready for your next challenge, this could be the perfect project for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Manage the authoring & drafting of all types of External Quality documentation. 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 Support quality metric management for external quality and partner teams. Coach & Train colleagues in Documentation System & GDP queries ABOUT YOU - ARE YOUR SKILLS A MATCH? 2+ years' experience in technical writing Proficient in data analytics, data visualization Working knowledge in Regulations, GMP, GDP Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please understand that we are unable to provide visa sponsorship. Thank you for your understanding. Apply via this advert or contact Sarina Abdulha at LSC on if you have any more questions about this opportunity! Skills: Deviation Handling Compliance CAPA Non Conformance GDP GMP