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Job Description
A Technical Writer is required for a biopharmaceutical company in South Dublin to manage and develop critical documentation.
The successful candidate will be responsible for owning and managing change controls, developing and maintaining operations procedures, and managing documentation updates.
Responsibilities:
- Develop and update operations procedures in accordance with site and corporate requirements.
- Serve as a document owner and assist in generation of training materials.
- Liaise with Manufacturing, Inspection, and Engineering regarding documentation changes.
- Develop protocols for execution in Manufacturing & Inspection in support of change controls and troubleshooting investigations.
- Participate in projects for continuous process improvement and troubleshooting.
- Manage change controls and issue updates of paper batch records in line with production schedule.
- Liaise with Quality Assurance to ensure GMP standards are maintained.
- Partner with Operations lead to ensure updates are correct and aligned with project deliverables.
- Perform document trending to identify key issues and mistakes in document processing.
- Support data verification of Operations owned protocols reports and risk assessments.
- Support the production support team in reducing document turnaround times.
- Use specified software packages and standard procedures to compile and maintain relevant documentation.
- Provide technical and clerical support to the manufacturing, inspection, and engineering teams.
- Ensure non-conformances are triaged within established goals and serve as a deviation owner for minor deviations.
- Own corrective and preventative actions and effectiveness verification.
- Support execution of C&Q, characterisation, functional testing protocols as required by project.
Qualifications and Experience:
- 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.