LSC have a great contract opportunity for 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.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- The Technical Writer will support the drafting, authoring and approval of SOP's and associated forms/Protocols/batch Records & other documents in conjunction with the various departmental subject matter experts (SME). These include QC, Manufacturing, Quality, EHS and Engineering) and support the processing through the change control and document control systems.
- Act as a SME/SuperUser on the Controlled Document System to facilitate the processing and approval of SOP's.
- Provide support and guidance to colleagues on systems and ad-hoc queries.
- Be proactive and collaborative in troubleshooting and resolving issues.
- Assisting with closure of Deviations/ CAPAs as required
- Initiate (& act as responsible person on) Change Requests & attend Change Request Board when required
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's Degree in a relevant area
- Proficiency with Microsoft office
- Experience with TrackWise desirable but not 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 Grainne Hodnett at LSC on 021-4777329 if you have any more questions about this opportunity!