A Technical Writer is required for a 12 month contract with LSC’s leading edge biotech client based in Cork. As Technical Writer you will be part of the Quality Group supporting Tech Transfer. As the Technical Writer you 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
-Involvement with Process Comparability where required.
Education and Experience:
-Minimum 2 years’ relevant experience in a cGMP regulated environment.
-Proficiency with Microsoft office, technical writing with exceptional organizational, spelling, grammar, and typing skills preferred.
-Experience with TrackWise desirable but not essential.
Call Evelyn at LSC on 021 4777329 to discuss or apply directly through this advert.