Job Opportunity
A leading Biotech company based in Ireland is seeking an experienced Technical Writer to join their team on a contract basis.
Main Responsibilities:
* Generate, review and update Standard Operating Procedures (SOPs).
* Collaborate with Manufacturing, Inspection and Engineering teams regarding documentation changes and updates.
* Develop protocols for execution in Manufacturing and Inspection in support of change controls, deviations and troubleshooting investigations with support from relevant Subject Matter Experts (SMEs).
* Manage change controls for Manufacturing, Inspection and Engineering.
* Liaise with Quality Assurance to ensure Good Manufacturing Practice (GMP) standards are upheld at all times.
* Utilize specified software packages and standard procedures to compile and maintain all relevant documentation, including SOPs.
* Provide technical and clerical support to the manufacturing, inspection and engineering teams in the preparation of documentation, data collation and SOP tracking.
* Own minor deviations as required.
Basic Qualifications:
* Degree in Science or Engineering discipline.
* Significant experience in Chemistry, Microbiology, Engineering or Validation gained within a Biotech or Pharmaceutical industry.
* Experience working in a GMP environment.
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