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 021-4777329 if you have any more questions about this opportunity!
