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Technical Writer Cleaning Validation

1 month ago

Limerick, Limerick, Ireland Quanta part of QCS Staffing Full time

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Technical Writer Cleaning Validation, Limerick

Client: Quanta part of QCS Staffing

Location: Limerick, Ireland

Job Category: Other

EU work permit required: Yes

Job Reference: 3caf12aa5dd1

Job Views: 4

Posted: 03.06.2025

Expiry Date: 18.07.2025

Job Description:

Technical Writer Cleaning Validation - Limerick - 12-Month Contract

Ireland is currently active in the Life Sciences Sector, with global companies establishing and expanding manufacturing facilities across the country. An exciting opportunity has arisen to work via Quanta on the client's side for a major expansion project with a global pharmaceutical organization in the Munster region of Ireland.

The manufacturing site is located approximately 20 minutes from the nearest international airport. The position requires onsite work five days a week, Monday to Friday, totaling 45 hours per week.

Role Summary:
  • Experienced Technical Writer with expertise in Deviation and Investigation writing
  • Experience in Validation, specifically CIP/SIP and ongoing validation processes
  • Ability to assess CIP/SIP issues during study runs and close deviations
  • Experience with KAYE validator reporting review is advantageous
  • Strong project management skills to handle large programs
  • Understanding of manufacturing processes and validation equipment for CIP and SIP
  • Ability to generate, review, and approve SIP protocols
  • Proficiency in generating and reviewing Summary Reports with a strong quality background
  • Experience in ongoing validation and assessment generation
  • Capability to work independently and manage multiple departments
  • Maintain and update Cleaning/SIP Validation Plans
  • Coordinate Cleaning/SIP activities with manufacturing
Must Have's:
  • Extensive experience in QA Validation activities, including execution, review, approval, and closure of SIP/CIP protocols
  • Proven track record in writing and approving Deviations
  • Technical writing experience, including white papers and site reports
  • Experience with continuing assessments in validation
  • Some exposure to GDP regulations is preferred
  • Previous administrative experience related to GDP is a plus

If this role interests you, please apply now

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