Job Description
A QA Validation Technical Writer is a key professional required to collaborate with our biotech client in Limerick, Ireland on a 12-month contract basis. The ideal candidate will possess relevant technical writing experience and the ability to execute complex validation protocols.
Key Responsibilities
* Executing site initiation protocol (SIP) and cleaning validation procedures
* Developing and approving GMP documents, including deviations
* Creating technical content for site reports
* Reviewing and approving SIP and CIP protocols
* Generating summary reports of validation results
* Assessing and resolving SIP/CIP issues during study runs and closing out related deviations
Requirements
* Bachelor's or Master's degree from a recognized institution
* Minimum two years' experience working within a Good Manufacturing Practice (GxP) environment
* Prior experience in commercial biologics manufacturing advantageous
* Experience in reviewing and reporting SIP/cleaning validation results beneficial
Note: A valid Irish work visa is mandatory for this position.