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Job Description
A Technical Writer is required for a biopharmaceutical company in South Dublin to manage and develop critical documentation.
Key responsibilities include:
- Developing and maintaining operations procedures in accordance with site and corporate requirements.
- Serving as a document owner and ensuring accuracy and alignment with project deliverables.
- Liaising with Manufacturing, Inspection, and Engineering teams regarding documentation changes.
- Developing protocols for execution in Manufacturing & Inspection in support of change controls and troubleshooting investigations.
- Participating in projects for continuous process improvement and troubleshooting.
- Issuing and updating paper batch records in line with production schedules.
- Liaising with Quality Assurance to ensure GMP standards are maintained.
- Partnering with Operations lead to ensure updates are correct and aligned with project timelines.
- Performing document trending to identify key issues and mistakes in document processing.
- Supporting data verification of Operations owned protocols reports and risk assessments.
- Supporting the production support team in reducing document turnaround times.
- Using specified software packages and standard procedures to compile and maintain relevant documentation.
- Providing technical and clerical support to the manufacturing, inspection, and engineering teams.
- Ensuring non-conformances are triaged within established goals and serving as a deviation owner for minor deviations.
- Own corrective and preventative actions and effectiveness verification.
- Supporting the execution of C&Q, characterisation, functional testing protocols as required by project.
Requirements:
- Bachelor's degree in a Science or Engineering discipline.
- 3+ years of experience in Chemistry, Microbiology, Engineering, or Validation gained within a biotech, pharma, or healthcare organization.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products is an advantage.
- Strong Project Management and organizational skills, including ability to follow assignments through to completion.
- Excellent verbal and written communication skills, including strong Technical writing skills for GMP documentation.