Technical Writer Cleaning Validation

2 weeks 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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