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Technical Writer

  • Job reference: 935994
  • Location: Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 11/06/2021

Orion Group Life Sciences have an exciting opportunity for a Technical Writer for our Multinational Biopharmaceutical client based in the North Dublin area on an initial 11-month contract.

The Technical Writer duties include management and creation of required business and system documents in adherence to appropriate standards during business or technical writing processes and projects.

Duties also include participation in system design sessions; proofreading and editing of prepared documents; research, assimilation, interpretation, formatting and publishing of information on new tools, systems and materials; the ability to use ingenuity and creative thinking during the preparation of needed documents in an organized, consistent, professional manner; while remaining current in system development methodologies and while remaining compliant with regulations concerning the development of systems and system documents.

Responsibilities:

  • Responsibility for the timely, accurate and efficient management of documents including access and revision control.
  • Manage "Live" Documentation updates from the operations floor.
  • Turnaround and issue documentation as per Operations Schedule
  • Manage and implement on the floor documentation control system.
  • Drive the Documentation Life Cycle System to ensure documents are approved in as per Scheduling requirements.
  • Work with various Subject Matter Experts to ensure technical documentation updates are approved.
  • Creation and revision of Standard operating Procedures (SOPs) Work Instructions (WI's) as required
  • Work closely with QA, Supply chain and Operations core functions
  • Ensure compliance with all regulatory GMP, Safety and Environmental requirements.
  • Support the deviation process including co-ordination of shift-based deviations and tracking to closure.
  • Assist in the write up of deviation incidents and link in with SMEs to address comments.
  • Manage day to day compliance metrics across the Upstream organization.
  • Support GMP Audit readiness and Compliance walkdowns.

Qualifications: At minimum level 6 in a relevant Qualification

For more information on this role, call Dan on +353 868140295 or email Daniel.ryan@orioneng.com for a confidential chat regarding this position.


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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