A leading Biotech company based in Dublin is seeking an experienced Technical Writer to join their team on an initial 12 month hourly rate contract.
Main Responsibilities:
* Generate, review & update Standard Operating Procedures.
* Collaborate with Manufacturing/Inspection/Engineering regarding documentation changes/updates etc.
* Generate protocols for execution in Manufacturing & Inspection in support of change controls, deviations & troubleshooting investigations with support from relevant SMEs.
* Management of change controls for Manufacturing/Inspection/Engineering.
* Liaise with Quality Assurance to ensure that GMP standards are upheld at all times.
* Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including SOPs.
* Provide technical and clerical support to the manufacturing, inspection & engineering teams in the preparation of documentation, collation of data and tracking of SOPs.
* Ownership of minor deviations as required.
Basic Qualifications:
* Degree in Science or Engineering discipline.
* Significant experience in Chemistry/Microbiology/Engineering/Validation gained within a Biotech or Pharma.
* Experience working in a GMP environment.
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