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Technical Writer

  • Sector: Science & Pharma
  • Contact Email:
  • Job Ref: 21068

***Technical Writer-Cork***

The Technical writer will function as a key member of the Process Development Services - Analytical Team. You’ll be responsible for drafting and revising Analytical Development (AD) documentation such as method validation protocols & reports, method transfer protocols & reports, reference standard qualification protocols & reports, quality control analytical methods & specifications.

Overview of Main Responsibilities (full job description available on request):

  • Drafting and revising Analytical Development (AD) documentation (protocols, reports, methods, and specifications, along with other documentation necessary to support the development and validation activities in the Process Development Services – Analytical Team.
  • Prepare documents and facilitate review and approval cycles to meet project timelines.
  • Critically review documentation for grammar, spelling, format, and style according to established guidelines.
  • Consult with analytical SMEs on technical requirements for documentation as well as consult relevant SOPs to assure compliance.
  • Create necessary guidelines and templates to standardize document content.
  • Clearly and accurately communicate the results of work by creating documentation of the testing/analysis and obtained results.
  • Record and report results of analysis in accordance with prescribed lab procedures and systems.
  • Coordinate and lead writing an updating of SOPs, policy manuals, and other instructional documents.
  • Obtain information in a timely manner, manage document changes from multiple sources, prioritize work to meet tight timeframes, build consensus with multiple reviewers and work to meet the department Right First Time (RFT) and On Time Delivery (OTD)
  • Prepare and manage Change control, deviation & CAPA in QMS
  • Update and manage lab work in LIMS

What the ideal candidate looks like:

  • Master's degree (MSc) /Bachelor degree in Chemistry, Analytical, or related field of study
  • Minimum 2 years of working with quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs, or related experience.
  • Reading, analysing and interpreting technical data to generate Analytical Development (AD) documentation. 

For a confidential discussion and more information on the role, please contact Aisling Lane.

(021) 4320675