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 5 years of experience in a GMP regulated environment and are ready for your next challenge, this could be the perfect project for you
EY RESPONSIBILITIES
* Lead, develop and implement process related documentation management strategy.
* Produce high-quality, accurate documentation, applying technical writing principles and best practice to ensure it is appropriate for its intended
* Perform technical writing, transition of documents to Veeva System and necessary editing to prepare documents, product & process/methods SOPs, reports, BPDs, Forms, Protocols, Reports, WI and other document types.
* Create, manage & maintain track changes, documentation repositories so that documentation is well organised and easily accessible. Act as the Subject Matter Expert (SME) for these repositories.
* Close collaborate with SME and teams to gain an in-depth understanding of the business and the product to inform documentation requirements.
* Ensure accuracy and consistency of technical documentation and ensure that it meets appropriate compliance standards.
* Suggest and implement continuous improvement to the technical writing process and toolset.
* Act as SME (Subject Matter Expert) on the Controlled Document System; Veeva Quality Documents. Provide support and guidance to colleagues on systems e.g. Veeva Quality Documents, Compliance Wire.
* Responsible for drafting, reviewing and approving SOPs, BPDs, Forms, Protocols, Reports, WI and other document types.
* Support of Technical Writing activities across site and collaborating which various departments SMEs.
* Perform transition of documentation to Veeva Quality Documents. Initiate Change Requests when required.
* Management of Compliance Wire activities as Department Training Administrator.
* Administration of training events within BCoE
* Be proactive and collaborative in troubleshooting and resolving issues.
Education and Experience (required):
* BSc. or MSc. qualification in a Science or an Engineering discipline, with approx. 5 years related proven experience in the technical document writing
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 Siobhan Cummins at LSC on if you have any more questions about this opportunity