C&Q Technical Writer
On behalf of our Client, a Global Pharmaceutical Company, Kenny-Whelan are hiring a C&Q Technical Writer for the Cork area.
Contact: Carmel Synnott on email: csynnott@kenny-whelan.ie or call on 087 7422268
Profile of the Role
The C&Q Tech Writer is responsible for the preparation of C&Q documentation to ensure that all installation and modification to new or existing facilities, equipment, local instruments and utilities is documented correctly and that existing equipment, instruments & utilities operate correctly and remain in a qualified state.
Main duties and responsibilities
Defining approaches and standards to enable C&Q activities to be carried out consistently and efficiently and in conformance with applicable regulatory expectations (quality, safety and/or environmental) and established industry standards (e.g. ISPE Guidelines etc.)
Generating / Updating procedures including templates.
Prepare demolition, mechanical completion, IV, OV documents in accordance with templates.
Prepare Risk Assessments, Commissioning & Qualification Plans, Verification Plans, Summary Reports and UR Documentation in accordance with templates.
Ensure all personnel and those executing protocols are adequately trained in C&Q procedures.
Ensure all commissioning & qualification documentation complies with all relevant local and global corporate procedures.
Represent C&Q on project teams advising the team on C&Q requirements.
Assist with C&Q training courses.
Reviewing engineering C&Q documents and coaching other technical staff on the C&Q business process and associated practices.
Building of technical data in the Engineering Data Management System.
Oversee the transfer of C&Q documentation into the site library.
Carry out & support audits as assigned both in-house, corporate and third party.
The C&Q Tech Writer will be expected to work closely with the other members of the Project Engineering Group, Maintenance, and members of the operational teams.
Previous Pharmaceutical/BioTech industry experience is essential for this role.
Please note
As this is a Contract role you need to be eligible to work in Ireland, hold a Stamp 1G or Stamp 4 Visa.
All applications will be treated with the strictest confidence
Kenny-Whelan Contact
For further information please contact Carmel Synnott 087 7422268 or send your updated CV to csynnott@kenny-whelan.ie
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