Main Purpose and Objectives of Position:
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.
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.
The Representative will routinely work with contract engineering resources, who will be allocated as required to supplement existing C&Q resources on site.
The following is a list of key skills/experience expected of the C&Q Tech Writer:
* Strong computer and technical writing skills.
* Organisational skills
* Excellent interpersonal skills including the ability to interact with others.
* Ability to work on own and as part of a team
* Strong attention to detail and proven levels of accuracy.
* Ability to multi-task, prioritise and manage time efficiently.
* Knowledge of Regulus system is desirable.
* Track record in delivery of GMP facilities / C&Q projects.
Educational Requirements: Third Level Engineering / Science Qualification or equivalent experience.
License/Certificate Requirements: N/A
Language Requirements: Proficient in English
Employment Type: Contract
Personal Considerations: The C&Q Representative may occasionally be required to travel off site, either within Ireland or abroad for short durations to attend meetings, visit vendors facilities or to receive training.
Key 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.
* Ensure that all commissioning & qualification documentation is executed in the correct order.
* Advise protocol executers on day to day activities on protocol issues.
* Ensure closure of protocols in a timely manner.
* Follow up on open discrepancies. Register and manage discrepancies for assigned projects.
* 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.
* As-Building of technical data in the Engineering Data Management System.
* Oversee the transfer of C&Q documentation into the site library.
* Ensure that C&Q databases are maintained to reflect current status.
* Assist other Departments as required in miscellaneous GMP activities (re-qualification protocols, Performance Qualification, etc.).
* Carry out & support audits as assigned both in-house, corporate and third party.
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