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